FDA applicant
Imperative Care, Inc.
FDA records 18 decisions for Imperative Care, Inc. (Campbell, CA) from 2018 to 2026: 18 510(k) clearances. Most are in product codes NRY (Catheter, Thrombus Retriever) and QJP (Catheter, Percutaneous, Neurovasculature). Since 2016 its 510(k)s took a median of 68 days from receipt to decision, against 129 for FDA’s reviews in the same codes and years. Its devices cite 22 predicates, 13 of them its own earlier devices. 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 Imperative Care, Inc.’s devices, and how often a recall has named them.
FDA decisions per year
6in 2025
2026 so far, outlined.
Recalls per year
1in 2021
Class I Class II/III not classified
Planning a device like Imperative Care, 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