510(k) Report

FDA applicant

Stoeckert Instrumente

North Attleboro, MA13 decisions1982–20010 recalls

FDA records 13 decisions for Stoeckert Instrumente (North Attleboro, MA) from 1982 to 2001: 13 510(k) clearances. Most are in product codes DTQ (Console, Heart-Lung Machine, Cardiopulmonary…) and DWB (Pump, Blood, Cardiopulmonary Bypass, Roller Type). Its devices cite 3 predicates, 3 of them its own earlier devices. 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 Stoeckert Instrumente’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Stoeckert Instrumente since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Stoeckert Instrumente 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?

  • DTQConsole, Heart-Lung Machine, Cardiopulmonary Bypass3decisions
  • DWBPump, Blood, Cardiopulmonary Bypass, Roller Type3decisions
  • DWFCatheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass2decisions
  • KRIAccessory Equipment, Cardiopulmonary Bypass2decisions
  • DTWMonitor And/Or Control, Level Sensing, Cardiopulmonary Bypass1decision
  • DTRHeat-Exchanger, Cardiopulmonary Bypass1decision

Also: DTB (1).

Who builds on its devices?

Later devices cite its devices 8 times; 3 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.

  • K950990Stockert S3 Roller Pump Module Stockert S3 ConsoleStoeckert Instrumente · 19962cite it
  • K982014Stockert Compact SystemStoeckert Instrumente · 19982cite it
  • K971520S3 Cyclic RPM ControlStoeckert Instrumente · 19972cite it
  • K955038Stockert S3 Double Head Pump ModuleStoeckert Instrumente · 19961cites it
  • K955152Stockert S3 Ups, LVL CTRL Bubb. Det., Dual Press. CTRL., Temp Mont., TimerStoeckert Instrumente · 19961cites it

What has FDA decided for it lately?

  • K002273Stockert A272 Series Pediatric Aortic CannulaeStoeckert Instrumente · 2001
  • K001961Stockert A242 and A252 Series Arterial Femoral CannulaeStoeckert Instrumente · 2001
  • K002118Stockert Compact System Version 2.0Stoeckert Instrumente · 2000
  • K992635Interface Module IdddStoeckert Instrumente · 1999
  • K990512Stockert Power Supply Unit for S3 ComponentsStoeckert Instrumente · 1999
  • K982014Stockert Compact SystemStoeckert Instrumente · 1998
  • K972321S3 Mast PumpStoeckert Instrumente · 1998
  • K971520S3 Cyclic RPM ControlStoeckert Instrumente · 1997

All 13 as Stoeckert Instrumente →