FDA applicant
Route 92 Medical, Inc.
FDA records 16 decisions for Route 92 Medical, Inc. (San Mateo, CA) from 2018 to 2026: 16 510(k) clearances. Most are in product codes QJP (Catheter, Percutaneous, Neurovasculature) and NRY (Catheter, Thrombus Retriever). Since 2016 its 510(k)s took a median of 104 days from receipt to decision, against 125 for FDA’s reviews in the same codes and years. Its devices cite 15 predicates, 9 of them its own earlier devices. 4 recalls are linked to its devices, 4 Class I.
FDA’s records also spell it “Route 92 Medical”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Route 92 Medical, Inc.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2025
2026 so far, outlined.
Recalls per year
4in 2024
Class I Class II/III not classified
Planning a device like Route 92 Medical, 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