510(k) Report

FDA applicant

Scott Laboratories, Inc.

Fiskeville, RI17 decisions1976–20131 recall

FDA records 17 decisions for Scott Laboratories, Inc. (Fiskeville, RI) from 1976 to 2013: 16 510(k) clearances and 1 original PMA approval. Most are in product codes JTO (Discs, Strips And Reagents, Microorganism…) and PDR (Computer-Assisted Personalized Sedation System). 1 recall is linked to its devices, 1 Class I.

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

FIG. A — Illustration, microbiology panel, where it files most

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

FDA decisions per year

1in 2013

2013: 1
2007high 1 (2013) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

1in 2015

2015: 1, 1 Class I
2007high 1 (2015) · low 0 (2007)2026

Class I Class II/III not classified

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

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Other applicant names beginning “Scott”

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