510(k) Report

FDA applicant

Glycar, Inc.

Dallas, TX5 decisions1994–19972 recalls

FDA records 5 decisions for Glycar, Inc. (Dallas, TX) from 1994 to 1997: 5 510(k) clearances. Most are in product codes FTL (Mesh, Surgical, Polymeric) and DXZ (Patch, Pledget And Intracardiac, Petp, Ptfe…). Its devices cite 3 predicates, 0 of them its own earlier devices. 2 recalls are linked to its devices, 2 Class I.

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 Glycar, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Glycar, Inc. since 2007.

Recalls per year

2in 2025

2025: 2, 2 Class I
2007high 2 (2025) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Glycar, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Glycar, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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Which product codes does it file in?

  • FTLMesh, Surgical, Polymeric2decisions
  • DXZPatch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene2decisions
  • FTMMesh, Surgical1decision

Whose devices does it build on?

Its devices cite 3 predicates; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 4 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.

  • K963967Glycar Pericardial PatchGlycar, Inc. · 19973cite it
  • K954665Glycar Staple StripsGlycar, Inc. · 19961cites it

What has FDA decided for it lately?

  • K963368Glycartissue Repair Patch Family of Products; Glycar Vascular Repair Patch Alternative Proprietary Name…Glycar, Inc. · 1997
  • K963967Glycar Pericardial PatchGlycar, Inc. · 19972 Class I recalls
  • K963175Glycar Tissue Repair Patch, Bio-Patch, Uro-SlingGlycar, Inc. · 1996
  • K954665Glycar Staple StripsGlycar, Inc. · 1996
  • K942911Glycar Tissue Repair PatchGlycar, Inc. · 1994

All 5 as Glycar, Inc. →

What has been recalled?

2 recalls linked to its devices; the latest:

  • K963967SJM Pericardial Patch, with EnCap Technology 5x10 cm, Model Number REF C0510; PATCH…Oct 9, 2025Class I
  • K963967SJM Pericardial Patch, with EnCap Technology 9x14cm, Model Number REF C0914; PATCH…Oct 9, 2025Class I