FDA applicant
Scott Laboratories, Inc.
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
How often FDA has decided Scott Laboratories, Inc.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2013
2026 so far, outlined.
Recalls per year
1in 2015
Class I Class II/III not classified
Planning a device like Scott 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) ReportOther applicant names beginning “Scott”
FDA records each applicant name separately; these may or may not be the same firm.