510(k) Report

FDA applicant

California Medical Laboratories, Inc.

Irvine, CA3 decisions1998–200010 recalls

FDA records 3 decisions for California Medical Laboratories, Inc. (Irvine, CA) from 1998 to 2000: 3 510(k) clearances. Most are in product codes DWF (Catheter, Cannula And Tubing, Vascular…) and DTS (Sucker, Cardiotomy Return, Cardiopulmonary…). 10 recalls are 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 California Medical Laboratories, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for California Medical Laboratories, Inc. since 2007.

Recalls per year

2in 2012

2008: 82012: 2
2007high 8 (2008) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — California Medical 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?

  • DWFCatheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass2decisions
  • DTSSucker, Cardiotomy Return, Cardiopulmonary Bypass1decision

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.

  • K982891California Medical Laboratories Inc. Standard and Small Rigid Tip Suction WandsCalifornia Medical Laboratories, Inc. · 19981cites it

What has FDA decided for it lately?

  • K000830Cannulation Tourniquet Set, 2 Tube or 5 TubeCalifornia Medical Laboratories, Inc. · 2000
  • K993818Antegrade/Retrograde Perfusion Adapter with or Without Pressure LineCalifornia Medical Laboratories, Inc. · 2000
  • K982891California Medical Laboratories Inc. Standard and Small Rigid Tip Suction WandsCalifornia Medical Laboratories, Inc. · 199810 recalls

All 3 as California Medical Laboratories, Inc. →

What has been recalled?

10 recalls linked to its devices; the latest:

  • K982891Sterile Rigid Tip Suction Wand The Suction Wands are indicated for use to remove excess…Nov 2, 2012Class II
  • K982891Rigid Tip Suction Wand Non sterile bulk devices (S112468N, S120196N, and S120197N) were…Nov 2, 2012Class II
  • K982891Terumo Sarns cardiovascular disposable products, Weighted Flexible Sucker, sterile…Feb 5, 2008
  • K982891Cardiovascular Procedure Kit, P/N 64789-01, Wisconsin Cardiovascular Services Pump and…Jan 29, 2008
  • K982891Cardiovascular Procedure Kit, P/N 70295-02, St. Louis University Hospital Pump & Table…Jan 29, 2008
  • K982891Cardiovascular Procedure Kit, P/N: 70932-01, HCSG-St. Mary's Hospital, Richmond, VA…Jan 29, 2008