510(k) Report

FDA applicant

Kensey Nash Corp.

Exton, PA25 decisions1993–201312 recalls

FDA records 25 decisions for Kensey Nash Corp. (Exton, PA) from 1993 to 2013: 25 510(k) clearances. Most are in product codes FTM (Mesh, Surgical) and NFA (Temporary Coronary Saphenous Vein Bypass Graft…). Its devices cite 43 predicates, 11 of them its own earlier devices. 12 recalls are linked to its devices.

FDA’s records also spell it “Kensey Nash Corporation”.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, general and plastic surgery panel, where it files most

How often FDA has decided Kensey Nash Corp.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2013

2007: 42008: 22009: 32010: 12011: 12012: 12013: 1
2007high 4 (2007) · low 0 (2014)2026

2026 so far, outlined.

Recalls per year

3in 2012

2007: 52010: 12012: 3
2007high 5 (2007) · low 0 (2008)2026

Class I Class II/III not classified

FIG. 1 — Kensey Nash Corp. 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?

  • FTMMesh, Surgical6decisions
  • NFATemporary Coronary Saphenous Vein Bypass Graft For Embolic Protection3decisions
  • NPLBarrier, Animal Source, Intraoral3decisions
  • MQVFiller, Bone Void, Calcium Compound3decisions
  • MCWCatheter, Peripheral, Atherectomy2decisions
  • GCJLaparoscope, General & Plastic Surgery2decisions

Also: QEZ (2), DQX (1), LZN (1), KGN (1), FTL (1).

Whose devices does it build on?

Its devices cite 43 predicates; 11 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 27 times; 11 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.

  • K043259Bioblanket Surgical MeshKensey Nash Corp. · 20053cite it
  • K041923BioblanketKensey Nash Corp. · 20043cite it
  • K060917Kensey Nash Bone Void FillerKensey Nash Corporation · 20063cite it
  • K042040Triactiv SystemKensey Nash Corp. · 20052cite it
  • K103787Medeor MatrixKensey Nash Corp. · 20112cite it
  • K071237Copios Bone Void Filler Sponge and PasteKensey Nash Corp. · 20072cite it

What has FDA decided for it lately?

  • K121310Mesothelium Dental MembraneKensey Nash Corporation · 2013
  • K112888Meso Wound MatrixKensey Nash Corporation · 2012
  • K103787Medeor MatrixKensey Nash Corp. · 2011
  • K094061Kensey Nash Ecm Surgical PatchKensey Nash Corporation · 2010
  • K091192Kensey Nash P1076 Collagen Dental Membrane, Model 20655-XXKensey Nash Corp. · 2009
  • K091499Medeor Matrix, Models 30010-XX (Hydrated); 30020-XX (Dry)Kensey Nash Corp. · 2009
  • K090919Kensey Nash Fibrillar Collagen Dental MembraneKensey Nash Corp. · 20093 recalls
  • K073519Quickcat Extraction Catheter, Model 60090-01Kensey Nash Corp. · 20081 recall

All 19 as Kensey Nash Corp. →All 6 as Kensey Nash Corporation →

What has been recalled?

12 recalls linked to its devices; the latest:

  • K090919a translucent, rectangular, resorbable, collagen membrane sheet derived from bovine…Feb 28, 2012
  • K090919a translucent, rectangular, resorbable, collagen membrane sheet derived from bovine…Feb 28, 2012
  • K090919a translucent, rectangular, resorbable, collagen membrane sheet derived from bovine…Feb 28, 2012
  • K060092Spectranetics Corporation, QuickCat Extraction Catheter, REF 60090-01, Sterile R…Jul 1, 2010
  • K060016ThromCat Thrombectomy Catheter System. Catalog number 63000-01May 21, 2007
  • K061772ProGuard Spare Shieldwire Inflators (2.5 - 5.0 mm), Catalog number 61030-01. The product…Mar 28, 2007

Other applicant names beginning “Kensey”

FDA records each applicant name separately; these may or may not be the same firm.

Kensey Nash Corporation Dba Dsm Biomedical 7Kensey Nash Cororation 1