510(k) Report

FDA applicant

Bentley Laboratories, Inc.

Mchenry, IL55 decisions1976–19930 recalls

FDA records 55 decisions for Bentley Laboratories, Inc. (Mchenry, IL) from 1976 to 1993: 55 510(k) clearances. Most are in product codes DTZ (Oxygenator, Cardiopulmonary Bypass) and DTN (Reservoir, Blood, Cardiopulmonary Bypass). No recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, cardiovascular panel, where it files most

How often FDA has decided Bentley Laboratories, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Bentley Laboratories, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Bentley Laboratories, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • DTZOxygenator, Cardiopulmonary Bypass10decisions
  • DTNReservoir, Blood, Cardiopulmonary Bypass6decisions
  • DTMFilter, Blood, Cardiopulmonary Bypass, Arterial Line6decisions
  • DRSTransducer, Blood-Pressure, Extravascular4decisions
  • DXYImplantable Pacemaker Pulse-Generator4decisions
  • KRACatheter, Continuous Flush2decisions

Also: KRI (2), FJI (2), KDI (2), KRJ (2), DTR (2), FIQ (1).

Who builds on its devices?

Later devices cite its devices 3 times; 0 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K820044Arterial Blood Filter, #AF-1025Bentley Laboratories, Inc. · 19822cite it
  • K903641Quick Prime Hemoconcen. NO. HQ-7000 and CBP-7000QBentley Laboratories, Inc. · 19901cites it

What has FDA decided for it lately?

  • K931967HE-30 GoldBentley Laboratories, Inc. · 1993
  • K913956Blood Cardioplegia Heat Exchanger, Model #HE-30Bentley Laboratories, Inc. · 1992
  • K913692Venous Reservoir Bag Model NO. BMR-250(TM)Bentley Laboratories, Inc. · 1991
  • K903641Quick Prime Hemoconcen. NO. HQ-7000 and CBP-7000QBentley Laboratories, Inc. · 1990
  • K894826Univox W/Holders, Models Univox-HL, HLB, HLFBentley Laboratories, Inc. · 1990
  • K874867Catr (TM)-H Cardiotomy HolderBentley Laboratories, Inc. · 1988
  • K874841Integrated Membrane Oxygenator W/Cardiotomy FilterBentley Laboratories, Inc. · 1988
  • K874618Baxter Accuport (TM) Central Venous CatheterBentley Laboratories, Inc. · 1988

All 55 as Bentley Laboratories, Inc. →