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Healthcare & Life SciencesUnited StatesUpdated 4 Nov 2026

Acute care needleless connector Market 2026: trade data and key figures

The FDA has 8 510(k) clearances on record for acute care needleless connector devices. In the US, the core industry (Surgical and medical instrument manufacturing) had 4,547 establishments in 2025. The EU counted 63,227 enterprises in the related industry class.

Edited by the Stratum Market Research editorial team. Updated 4 Nov 2026.

Headline figure

8510(k) clearances

FDA 510(k) clearances on record

FDA 510(k) clearances per year, acute care needleless connector20162025 U.S. Food and Drug Administration, 4 Nov 2026

63,227 enterprises

The EU had 63,227 enterprises in NACE class C3250 (Manufacture of medical and dental instruments and supplies) in 2023.

Eurostat

105.31 EUR billion

EU enterprises in NACE class C3250 had net turnover of €105.31 billion in 2021.

Eurostat

600,000 persons employed

NACE class C3250 employed 600,000 people across the EU in 2023.

Eurostat
ChartFDA 510(k) clearances per year, acute care needleless connector
FDA 510(k) clearances per year, acute care needleless connector00.511.522016: 0 clearances020162017: 1 clearances2018: 0 clearances20182019: 0 clearances2020: 0 clearances20202021: 2 clearances2022: 1 clearances20222023: 1 clearances2024: 0 clearances2025: 0 clearances02025

Source: U.S. Food and Drug Administration (openFDA)

Why this market is moving now

  • US employment in the core industry shifted +4% since 2020.

What this market covers

Valves on intravenous lines that let nurses connect syringes and tubing without needles. Hospitals use them to lower needlestick injury and infection risk.

Typical segments

  • Positive displacement connectors
  • Negative displacement connectors
  • Neutral connectors
  • Antimicrobial connectors

Who buys

  • Hospitals
  • Infusion centres
  • Group purchasing organisations

Key figures

Each figure links to the page it came from.

FigureValueYearSource
The EU had 63,227 enterprises in NACE class C3250 (Manufacture of medical and dental instruments and supplies) in 2023.63,227 enterprises2023Eurostat
EU enterprises in NACE class C3250 had net turnover of €105.31 billion in 2021.105.31 EUR billion2021Eurostat
NACE class C3250 employed 600,000 people across the EU in 2023.600,000 persons employed2023Eurostat
The US had 4,547 private establishments in NAICS 339112 (Surgical and medical instrument manufacturing) in 2025.4,547 establishments2025U.S. Bureau of Labor Statistics
NAICS 339112 employed an average of 140,413 people in US private industry in 2025.140,413 jobs2025U.S. Bureau of Labor Statistics
US employment in NAICS 339112 changed by +4% between 2020 (135,655 jobs) and 2025, calculated from BLS figures.+4 % change2025U.S. Bureau of Labor Statistics
Average annual pay in US NAICS 339112 was $109,475 in 2025.109,475 USD per year2025U.S. Bureau of Labor Statistics
The FDA has recorded 8 510(k) clearances for devices named "needleless connector".8 510(k) clearances2026U.S. Food and Drug Administration (openFDA)
4 of those clearances were issued from 2021 to 2025.4 510(k) clearances2025U.S. Food and Drug Administration (openFDA)
Puracath Medical, Inc. holds 2 510(k) clearances for devices named "needleless connector".2 510(k) clearances2026U.S. Food and Drug Administration (openFDA)
Amsino International, Inc. holds 1 510(k) clearances for devices named "needleless connector".1 510(k) clearances2026U.S. Food and Drug Administration (openFDA)
Becton, Dickinson And Company holds 1 510(k) clearances for devices named "needleless connector".1 510(k) clearances2026U.S. Food and Drug Administration (openFDA)
Churchill Medical Systems, Inc. holds 1 510(k) clearances for devices named "needleless connector".1 510(k) clearances2026U.S. Food and Drug Administration (openFDA)
Intravascular Incorporated holds 1 510(k) clearances for devices named "needleless connector".1 510(k) clearances2026U.S. Food and Drug Administration (openFDA)
Jiangsu Caina Medical Co.,Ltd holds 1 510(k) clearances for devices named "needleless connector".1 510(k) clearances2026U.S. Food and Drug Administration (openFDA)
PubMed indexed 6 papers mentioning "needleless connector" in the title or abstract in 2025.6 papers2025U.S. National Library of Medicine (PubMed)

Companies to watch

Puracath Medical, Inc.

2 FDA 510(k) clearances for devices named "needleless connector".

Amsino International, Inc.

1 FDA 510(k) clearances for devices named "needleless connector".

Becton, Dickinson And Company

1 FDA 510(k) clearances for devices named "needleless connector".

Churchill Medical Systems, Inc.

1 FDA 510(k) clearances for devices named "needleless connector".

Intravascular Incorporated

1 FDA 510(k) clearances for devices named "needleless connector".

Jiangsu Caina Medical Co.,Ltd

1 FDA 510(k) clearances for devices named "needleless connector".

What the full report covers

Illustration of a report page with its five main parts numbered12345
  1. 1

    Executive summary

    The answer on two pages: size, growth and what drives it.

  2. 2

    Market size and outlook

    History, the current year and a five-year view with base, low and high cases.

  3. 3

    Segments and regions

    Splits by product, buyer and geography across the US, Europe and MEA.

  4. 4

    Company profiles

    The main players, how they compete and where they are investing.

  5. 5

    Data and method

    Every figure in Excel, with the sources and assumptions behind it.

  1. 01Executive summary
    The answer in one page: size, direction and what moves it
  2. 02Market definition and scope
    What is in and out of the United States market
  3. 03Market size, 2021 to 2025
    Historical series and growth rates
  4. 04Outlook to 2031
    Base, low and high scenarios with stated assumptions
  5. 05Rules, policy and deadlines
    Regulation and programmes that change demand
  6. 06Drivers and barriers
    What accelerates or slows adoption, by customer segment
  7. 07Prices, costs and margins
    Unit economics where public data allows
  8. 08Competitive landscape
    8 to 12 company profiles with recent moves
  9. 09Opportunities and risks
    For new entrants, suppliers and investors
  10. 10Method and sources
    Every assumption and source, listed

Included with the full report

  • PDF report, 40 to 60 pages
  • Excel data pack
  • Ready-to-use charts
  • Method note and assumptions
  • Written to order in 5 working days

Frequently asked questions

How many acute care needleless connector devices are cleared by the FDA?

openFDA lists 8 510(k) clearances for devices named needleless connector.

Which companies hold the most FDA clearances for acute care needleless connector?

By 510(k) count: Puracath Medical, Inc., Amsino International, Inc., Becton, Dickinson And Company, Churchill Medical Systems, Inc..

How many US companies are in the acute care needleless connector industry?

BLS counts 4,547 private establishments in NAICS 339112 (Surgical and medical instrument manufacturing), the closest official industry.

How many EU companies are in the acute care needleless connector industry?

Eurostat counts 63,227 enterprises in NACE class C3250 (Manufacture of medical and dental instruments and supplies).

Sources and method

The figures on this page come from the public sources listed below. Read how we work.

  1. Eurostat: Enterprises by detailed NACE Rev. 2 activity and special aggregates (sbs_ovw_act) (2026-11-04)sbs_ovw_act, geo EU27_2020, nace_r2 C3250, indic_sbs ENT_NR, 2023, 63227
  2. Eurostat: Enterprises by detailed NACE Rev. 2 activity and special aggregates (sbs_ovw_act) (2026-11-04)sbs_ovw_act, geo EU27_2020, nace_r2 C3250, indic_sbs NETTUR_MEUR, 2021, 105308
  3. Eurostat: Enterprises by detailed NACE Rev. 2 activity and special aggregates (sbs_ovw_act) (2026-11-04)sbs_ovw_act, geo EU27_2020, nace_r2 C3250, indic_sbs EMP_NR, 2023, 600000
  4. U.S. Bureau of Labor Statistics: QCEW annual averages, NAICS 339112, 2025 (2026-11-04)QCEW 2025 annual, US000, private, NAICS 339112, annual_avg_estabs 4547
  5. U.S. Bureau of Labor Statistics: QCEW annual averages, NAICS 339112, 2025 (2026-11-04)QCEW 2025 annual, US000, private, NAICS 339112, annual_avg_emplvl 140413
  6. U.S. Bureau of Labor Statistics: QCEW annual averages, NAICS 339112, 2025 (2026-11-04)QCEW 2020 annual_avg_emplvl 135655; 2025 annual_avg_emplvl 140413
  7. U.S. Bureau of Labor Statistics: QCEW annual averages, NAICS 339112, 2025 (2026-11-04)QCEW 2025 annual, US000, private, NAICS 339112, avg_annual_pay 109475
  8. U.S. Food and Drug Administration (openFDA): openFDA 510(k) clearances, device_name "needleless connector" (2026-11-04)openFDA device/510k device_name:"needleless connector", sum of counts by decision_date = 8
  9. U.S. Food and Drug Administration (openFDA): openFDA 510(k) clearances, device_name "needleless connector" (2026-11-04)openFDA device/510k decision_date 2021-2025 count = 4
  10. U.S. Food and Drug Administration (openFDA): openFDA 510(k) clearances by applicant, device_name "needleless connector" (2026-11-04)applicant.exact "Puracath Medical, Inc." count 2
  11. U.S. Food and Drug Administration (openFDA): openFDA 510(k) clearances by applicant, device_name "needleless connector" (2026-11-04)applicant.exact "Amsino International, Inc." count 1
  12. U.S. Food and Drug Administration (openFDA): openFDA 510(k) clearances by applicant, device_name "needleless connector" (2026-11-04)applicant.exact "Becton, Dickinson and Company" count 1
  13. U.S. Food and Drug Administration (openFDA): openFDA 510(k) clearances by applicant, device_name "needleless connector" (2026-11-04)applicant.exact "Churchill Medical Systems, Inc." count 1
  14. U.S. Food and Drug Administration (openFDA): openFDA 510(k) clearances by applicant, device_name "needleless connector" (2026-11-04)applicant.exact "Intravascular Incorporated" count 1
  15. U.S. Food and Drug Administration (openFDA): openFDA 510(k) clearances by applicant, device_name "needleless connector" (2026-11-04)applicant.exact "Jiangsu Caina Medical Co.,Ltd" count 1
  16. U.S. National Library of Medicine (PubMed): PubMed search "needleless connector"[tiab] AND 2025[dp] (2026-11-04)esearch count 6

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