510(k) Report

FDA applicant

Olson Medical Sales, Inc.

Somerset, NJ4 decisions1999–20011 recall

FDA records 4 decisions for Olson Medical Sales, Inc. (Somerset, NJ) from 1999 to 2001: 4 510(k) clearances. Most are in product codes DWE (Tubing, Pump, Cardiopulmonary Bypass) and DTL (Adaptor, Stopcock, Manifold, Fitting…). Its devices cite 4 predicates, 0 of them its own earlier devices. 1 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 Olson Medical Sales, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Olson Medical Sales, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Olson Medical Sales, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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Which product codes does it file in?

  • DWETubing, Pump, Cardiopulmonary Bypass1decision
  • DTLAdaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass1decision
  • JODFilter, Blood, Cardiotomy Suction Line, Cardiopulmonary Bypass1decision
  • DTRHeat-Exchanger, Cardiopulmonary Bypass1decision

Whose devices does it build on?

Its devices cite 4 predicates; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 1 time; 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.

  • K992906Components for Cardiovascular Procedure KitOlson Medical Sales, Inc. · 19991cites it

What has FDA decided for it lately?

  • K000977Components for Cardiovascular Procedure Kit - Heat Exchanger CoilsOlson Medical Sales, Inc. · 20011 recall
  • K993060Gas FilterOlson Medical Sales, Inc. · 2000
  • K993062Chest Drainage TubingOlson Medical Sales, Inc. · 1999
  • K992906Components for Cardiovascular Procedure KitOlson Medical Sales, Inc. · 1999

All 4 as Olson Medical Sales, Inc. →

What has been recalled?

1 recall linked to its devices; the latest:

  • K000977Heat Exchanger Coil (code Number 0006-0011) used in the ''Custom Cardiovascular…Nov 7, 2002