FDA applicant
Smiths Medical Asd, Inc.
FDA records 53 decisions for Smiths Medical Asd, Inc. (Keene, NH) from 1991 to 2024: 52 510(k) clearances and 1 original PMA approval. Most are in product codes FMI (Needle, Hypodermic, Single Lumen) and JOH (Tube Tracheostomy And Tube Cuff). Since 2016 its 510(k)s took a median of 209 days from receipt to decision, against 182 for FDA’s reviews in the same codes and years. Its devices cite 87 predicates, 22 of them its own earlier devices. 35 recalls are linked to its devices, 11 Class I.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Smiths Medical Asd, Inc.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2024
2026 so far, outlined.
Recalls per year
1in 2026
Class I Class II/III not classified
Planning a device like Smiths Medical Asd, 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.