510(k) Report

FDA applicant

Steridyne Laboratories, Inc.

Washington, DC2 decisions1987–19870 recalls

FDA records 2 decisions for Steridyne Laboratories, Inc. (Washington, DC) in 1987: 2 510(k) clearances. All are in product code FRO (Dressing, Wound, Drug). 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 Steridyne Laboratories, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Steridyne Laboratories, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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

See the 510(k) Report

Other applicant names beginning “Steridyne”

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