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Healthcare & Life SciencesUnited StatesUpdated 4 Nov 2026

Hemoconcentrators Market 2026: trade data and key figures

The FDA has 25 510(k) clearances on record for hemoconcentrators 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.

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Region
United States
Evidence
15 sourced figures from 4 sources
Last checked
4 Nov 2026

25510(k) clearances

FDA 510(k) clearances on record

63,227enterprises

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

105.31EUR billion

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

600,000persons employed

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

OverviewDataBuyers and suppliersWhat is insideFAQ

What this market covers

Filters that remove excess water from blood during heart surgery on a bypass machine, sized for adult and pediatric patients. Hospitals buy them with perfusion supplies.

Typical segments

  • Adult hemoconcentrators
  • Pediatric hemoconcentrators
  • Neonatal units
  • Bypass circuit packs
Illustrative

Why this market is moving now

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

Key figures

Each figure names the source it came from. Open the source list below to read the quoted line.

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 25 510(k) clearances for devices named "hemoconcentrator".25 510(k) clearances2026U.S. Food and Drug Administration
3 of those clearances were issued from 2021 to 2025.3 510(k) clearances2025U.S. Food and Drug Administration
Minntech Corp. holds 5 510(k) clearances for devices named "hemoconcentrator".5 510(k) clearances2026U.S. Food and Drug Administration
Amicon, Inc. holds 2 510(k) clearances for devices named "hemoconcentrator".2 510(k) clearances2026U.S. Food and Drug Administration
Research Medical, Inc. holds 2 510(k) clearances for devices named "hemoconcentrator".2 510(k) clearances2026U.S. Food and Drug Administration
Sorin Group Italia S.R.L. holds 2 510(k) clearances for devices named "hemoconcentrator".2 510(k) clearances2026U.S. Food and Drug Administration
Baxter Healthcare Corp holds 1 510(k) clearances for devices named "hemoconcentrator".1 510(k) clearances2026U.S. Food and Drug Administration
C.R. Bard, Inc. holds 1 510(k) clearances for devices named "hemoconcentrator".1 510(k) clearances2026U.S. Food and Drug Administration

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)
    Quoted lines
    • Figure 1sbs_ovw_act, geo EU27_2020, nace_r2 C3250, indic_sbs ENT_NR, 2023, 63227
    • Figure 2sbs_ovw_act, geo EU27_2020, nace_r2 C3250, indic_sbs NETTUR_MEUR, 2021, 105308
    • Figure 3sbs_ovw_act, geo EU27_2020, nace_r2 C3250, indic_sbs EMP_NR, 2023, 600000
  2. U.S. Bureau of Labor Statistics: QCEW annual averages, NAICS 339112, 2025 (2026-11-04)
    Quoted lines
    • Figure 4QCEW 2025 annual, US000, private, NAICS 339112, annual_avg_estabs 4547
    • Figure 5QCEW 2025 annual, US000, private, NAICS 339112, annual_avg_emplvl 140413
    • Figure 6QCEW 2020 annual_avg_emplvl 135655; 2025 annual_avg_emplvl 140413
    • Figure 7QCEW 2025 annual, US000, private, NAICS 339112, avg_annual_pay 109475
  3. U.S. Food and Drug Administration: openFDA 510(k) clearances, device_name "hemoconcentrator" (2026-11-04)
    Quoted lines
    • Figure 8openFDA device/510k device_name:"hemoconcentrator", sum of counts by decision_date = 25
    • Figure 9openFDA device/510k decision_date 2021-2025 count = 3
  4. U.S. Food and Drug Administration: openFDA 510(k) clearances by applicant, device_name "hemoconcentrator" (2026-11-04)
    Quoted lines
    • Figure 10applicant.exact "Minntech Corp." count 5
    • Figure 11applicant.exact "Amicon, Inc." count 2
    • Figure 12applicant.exact "Research Medical, Inc." count 2
    • Figure 13applicant.exact "Sorin Group Italia S.R.L." count 2
    • Figure 14applicant.exact "Baxter Healthcare Corp" count 1
    • Figure 15applicant.exact "C.R. Bard, Inc." count 1

Buyers and suppliers

Who buys

  • Hospitals
  • Cardiac surgery centers
  • Perfusion service providers

Companies to watch

Minntech Corp.

5 FDA 510(k) clearances for devices named "hemoconcentrator".

Amicon, Inc.

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

Research Medical, Inc.

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

Sorin Group Italia S.R.L.

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

Baxter Healthcare Corp

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

C.R. Bard, Inc.

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

What the full report covers

  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
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Frequently asked questions

How many hemoconcentrators devices are cleared by the FDA?

openFDA lists 25 510(k) clearances for devices named hemoconcentrator.

Which companies hold the most FDA clearances for hemoconcentrators?

By 510(k) count: Minntech Corp., Amicon, Inc., Research Medical, Inc., Sorin Group Italia S.R.L..

How many US companies are in the hemoconcentrators 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 hemoconcentrators industry?

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

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