510(k) Report

FDA applicant

Pioneering Technologies, Inc.

Wheat Ridge, CO19 decisions1988–19921 recall

FDA records 19 decisions for Pioneering Technologies, Inc. (Wheat Ridge, CO) from 1988 to 1992: 19 510(k) clearances. Most are in product codes DWS (Instruments, Surgical, Cardiovascular) and DSY (Prosthesis, Vascular Graft, Of 6mm And Greater…). 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 Pioneering Technologies, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Pioneering Technologies, Inc. since 2007.

Recalls per year

1in 2012

2012: 1
2007high 1 (2012) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Pioneering Technologies, 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?

  • DWSInstruments, Surgical, Cardiovascular3decisions
  • DSYProsthesis, Vascular Graft, Of 6mm And Greater Diameter3decisions
  • DWFCatheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass2decisions
  • DXCClamp, Vascular2decisions
  • KRHRing, Annuloplasty1decision
  • DWPDilator, Vessel, Surgical1decision

Also: DRE (1), KGO (1), EFQ (1), GXY (1), DWC (1), GAQ (1).

Who builds on its devices?

Later devices cite its devices 6 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.

  • K905175Pti Annuloplasty Ring (Sterile)Pioneering Technologies, Inc. · 19925cite it
  • K901575Reusable Tens Paravertebral Pad #641 Back ElectrodPioneering Technologies, Inc. · 19901cites it

What has FDA decided for it lately?

  • K922025Anastomart (TM) Coronary Bypass Graft Markers/ModifPioneering Technologies, Inc. · 1992
  • K905175Pti Annuloplasty Ring (Sterile)Pioneering Technologies, Inc. · 1992
  • K905068Pti Intra-Art (TM) Pick-UP WicksPioneering Technologies, Inc. · 1991
  • K910067Pti Sternal Closure Wire SuturePioneering Technologies, Inc. · 1991
  • K905067Pti Anastomark Flexible Coronary Bypass GraftPioneering Technologies, Inc. · 1991
  • K901815Modified Sterilization of Intra-Art (TM) CoronaryPioneering Technologies, Inc. · 1990
  • K901682Pti Anastomark (TM) Coronary Bypass Graft MarkersPioneering Technologies, Inc. · 1990
  • K901531Pti Intra-Artr Reusable Coronary Artery ProbePioneering Technologies, Inc. · 1990

All 19 as Pioneering Technologies, Inc. →

What has been recalled?

1 recall linked to its devices; the latest:

  • K901575Reusable, non-sterile, self-adhering electrodes for use with TENS/NMES, . Made in the…Feb 9, 2012Class II