510(k) Report

FDA applicant

Carbomedics, Inc.

Austin, TX23 decisions1979–19974 recalls

FDA records 23 decisions for Carbomedics, Inc. (Austin, TX) from 1979 to 1997: 22 510(k) clearances and 1 original PMA approval. Most are in product codes LYC (Bone Grafting Material, Synthetic) and DTJ (Holder, Heart-Valve, Prosthesis). Its devices cite 5 predicates, 2 of them its own earlier devices. 4 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 Carbomedics, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Carbomedics, Inc. since 2007.

Recalls per year

2in 2015

2009: 12015: 2
2007high 2 (2015) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Carbomedics, 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?

  • LYCBone Grafting Material, Synthetic3decisions
  • DTJHolder, Heart-Valve, Prosthesis3decisions
  • DSYProsthesis, Vascular Graft, Of 6mm And Greater Diameter3decisions
  • DZEImplant, Endosseous, Root-Form2decisions
  • MOPRotator, Prosthetic Heart Valve2decisions
  • DTISizer, Heart-Valve, Prosthesis2decisions

Also: MAL (1), JDL (1), JDI (1), JDG (1), DXO (1), KWL (1).

Whose devices does it build on?

Its devices cite 5 predicates; 2 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 8 times; 2 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.

  • K951368Carbomedics Exended Mitral RotatorCarbomedics, Inc. · 19953cite it
  • P890045Gelseal TM Triaxial Vascular GraftCarbomedics, Inc. · 19931cites it
  • K942736Carbomedics (R) Prosthetic Heart Valve Holder HandleCarbomedics, Inc. · 19941cites it
  • K964665Vascutek Gelweave Vascular Graft (Bifurcated Configuration)Carbomedics, Inc. · 19971cites it
  • K962154Carbomedics HandleCarbomedics, Inc. · 19961cites it
  • K970375Annuloflo SystemCarbomedics, Inc. · 19971cites it

What has FDA decided for it lately?

  • K970375Annuloflo SystemCarbomedics, Inc. · 1997
  • K964665Vascutek Gelweave Vascular Graft (Bifurcated Configuration)Carbomedics, Inc. · 1997
  • K962154Carbomedics HandleCarbomedics, Inc. · 1996
  • K960923Carbomedics Mitral RotatorCarbomedics, Inc. · 1996
  • K960706Vascutek Vascusoft Plus Vascular GraftCarbomedics, Inc. · 1996
  • K960169Carbomedics Valve TesterCarbomedics, Inc. · 19961 recall
  • K955588Vascutek Graft Sizer SetCarbomedics, Inc. · 1996
  • K952184Carbomedics Supra-Annular Valve SizerCarbomedics, Inc. · 1995

All 23 as Carbomedics, Inc. →

What has been recalled?

4 recalls linked to its devices; the latest:

  • P890045Gelseal Straight Diameter 8mm Length 15cm. Vascular graft prosthesis is an implanted…May 15, 2015Class II
  • P890045Gelseal Straight Diameter 8mm Length 30cm. Vascular graft prosthesis is an implanted…May 15, 2015Class II
  • K811101Zimmer Dental Calcitite 4060-2 Dense Nonresorbable Hydroxylapatite Bone Grafting…Jan 22, 2009
  • K960169Carbomedics VT-200 Valve TesterApr 30, 2002