FDA applicant
Smiths Industries Medical Systems, Inc.
FDA records 23 decisions for Smiths Industries Medical Systems, Inc. (Keene, NH) from 1990 to 1998: 22 510(k) clearances and 1 original PMA approval. Most are in product codes FMI (Needle, Hypodermic, Single Lumen) and JOH (Tube Tracheostomy And Tube Cuff). Its devices cite 3 predicates, 1 of them its own earlier devices. 41 recalls are linked to its devices.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Smiths Industries Medical Systems, Inc.’s devices, and how often a recall has named them.
FDA decisions per year
No FDA decision for Smiths Industries Medical Systems, Inc. since 2007.
Recalls per year
2in 2025
Class I Class II/III not classified
Planning a device like Smiths Industries Medical Systems, 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 “Smiths”
FDA records each applicant name separately; these may or may not be the same firm.