510(k) Report

FDA applicant

3t Medical Systems, LLC

Conifer, CO5 decisions2001–200736 recalls

FDA records 5 decisions for 3t Medical Systems, LLC (Conifer, CO) from 2001 to 2007: 5 510(k) clearances. Most are in product codes KRI (Accessory Equipment, Cardiopulmonary Bypass) and DTN (Reservoir, Blood, Cardiopulmonary Bypass). 36 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 3t Medical Systems, LLC’s devices, and how often a recall has named them.

FDA decisions per year

1in 2007

2007: 1
2007high 1 (2007) · low 0 (2008)2026

2026 so far, outlined.

Recalls per year

36in 2011

2011: 36
2007high 36 (2011) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — 3t Medical Systems, LLC 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?

  • KRIAccessory Equipment, Cardiopulmonary Bypass1decision
  • DTNReservoir, Blood, Cardiopulmonary Bypass1decision
  • EZLCatheter, Retention Type, Balloon1decision
  • MJJCpb Check Valve, Retrograde Flow, In-Line1decision
  • DWFCatheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass1decision

What has FDA decided for it lately?

  • K0726973T Blood Collection Cardiotomy Reservoirs and Accessories3t Medical Systems, LLC · 2007
  • K0222873T/Sewoon Temperature Sensing Foley Catheters3t Medical Systems, LLC · 2002
  • K0207683T Vessel Cannulas3t Medical Systems, LLC · 2002
  • K0203653TM Myocardial Needle-Temperature Probe3t Medical Systems, LLC · 2002
  • K0012453T L. V. Control Valve3t Medical Systems, LLC · 200136 recalls

All 5 as 3t Medical Systems, LLC →

What has been recalled?

36 recalls linked to its devices; the latest:

  • K001245Cardiovascular Custom Procedure Kits, REV.2, REV. 3 PUMP & TABLE PACK 1/4 Terumo…Aug 11, 2011
  • K001245Cardiovascular Custom Procedure Kits, REV: 5 STANDARD PACK Item Number: 71701 Terumo…Aug 11, 2011
  • K001245Cardiovascular Custom Procedure Kits, Rev O, REV 1, REV 1A, REV 2 X-COATED 8:1 FX PACK…Aug 11, 2011
  • K001245Cardiovascular Custom Procedure Kits, REV: 4 FX, CP50 CENT. PK Item Number: 73386 Terumo…Aug 11, 2011
  • K001245Cardiovascular Custom Procedure Kits, REV.0 REV.0A, REV.1 X-Coated 4:1 CP50 FX Pack Item…Aug 11, 2011
  • K001245Cardiovascular Custom Procedure Kits, REV : 3 General Low Prime Item Number: 73563…Aug 11, 2011