510(k) Report

FDA applicant

Superstat Corp.

Rancho Dominguez1 decision1982–198213 recalls

FDA records 1 decision for Superstat Corp. (Rancho Dominguez) in 1982: 1 original PMA approval. All are in product code LMF (Agent, Absorbable Hemostatic, Collagen Based). 13 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, general and plastic surgery panel, where it files most

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

FDA decisions per year

No FDA decision for Superstat Corp. since 2007.

Recalls per year

13in 2012

2012: 13
2007high 13 (2012) · low 0 (2007)2026

Class I Class II/III not classified

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

Planning a device like Superstat Corp.’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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