510(k) Report

FDA applicant

Starch Medical, Inc.

San Jose, CA2 decisions2023–20240 recalls

FDA records 2 decisions for Starch Medical, Inc. (San Jose, CA) from 2023 to 2024: 2 510(k) clearances. All are in product code QSY (Hemostatic Wound Dressing Without Thrombin Or…). Its devices cite 2 predicates, 1 of them its own earlier devices. No recall is linked to its devices.

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

How often FDA has decided Starch Medical, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2024

2023: 12024: 1
2023high 1 (2023) · low 0 (2025)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2023.

FIG. 1 — Starch Medical, Inc. by year, 2023–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • QSYHemostatic Wound Dressing Without Thrombin Or Other Biologics2decisions

Whose devices does it build on?

Its devices cite 2 predicates; 1 are its own earlier devices. The firms it cites most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K220525RESPONDER Polysaccharide HemostatStarch Medical, Inc. · 20231cites it

What has FDA decided for it lately?

  • K240454RESPONDER® Polysaccharide HemostatStarch Medical, Inc. · 2024
  • K220525RESPONDER Polysaccharide HemostatStarch Medical, Inc. · 2023

All 2 as Starch Medical, Inc. →