# Route 92 Medical, Inc.

- Location (FDA's records): San Mateo, CA
- FDA decisions: 16 (2018–2026): 16 510(k) clearances
- Names in FDA's records: Route 92 Medical, Inc. (15); Route 92 Medical (1)
- Product codes: QJP (8), NRY (4), DQY (4)
- 510(k) review time since 2016: median 104 days, against 125 for FDA's reviews in the same codes and years (7 of 16 faster)
- Predicates its devices cite: 15 (9 its own); citations of its devices by later devices: 13 (9 its own)
- Recalls linked to its devices: 4 (4 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Penumbra, Inc.: 2 (https://510kreport.com/company/penumbra)
- Stryker Neurovascular: 1 (https://510kreport.com/company/stryker-neurovascular)
- Imperative Care, Inc.: 1 (https://510kreport.com/company/imperative-care)
- Mivi Neuroscience, Inc.: 1 (https://510kreport.com/company/mivi-neuroscience)
- Tni Manufacturing, Inc.: 1 (https://510kreport.com/company/tni-manufacturing)

## Firms that cite its devices most
- Perfuze, Ltd.: 2 (https://510kreport.com/company/perfuze)
- Unity Medical, Inc.: 1 (https://510kreport.com/company/unity-medical)
- Balt USA, LLC: 1 (https://510kreport.com/company/balt-usa)

## Its most-cited devices
- K182512: Route 92 Medical Delivery Catheter (2018), cited by 2
- K201518: Route 92 Medical 088 Access System (2020), cited by 2
- K200121: Route 92 Medical 088 Access System, 110 cm (2020), cited by 2
- K191717: Route 92 Medical Sheath System (2020), cited by 2
- K231583: Route 92 Medical Full Length 054 Access System (2023), cited by 1
- K222743: Route 92 Medical Full Length 070 Access System (2022), cited by 1

## Recent decisions
- K263266: Route 92 Medical Full Length 046 Reperfusion System and Aspiration Tubing Set (Oct 16, 2026)
- K260220: Route 92 Medical Full Length 046 Access System (Sep 16, 2026)
- K243601: Route 92 Medical HiPoint Reperfusion System and Aspiration Tubing Set (May 19, 2025)
- K240529: 8F Modified Sheath System (Oct 2, 2024)
- K233329: Route 92 Medical Full Length 054 Reperfusion System and Aspiration Tubing Set (Apr 23, 2024)
- K231583: Route 92 Medical Full Length 054 Access System (Aug 15, 2023)
- K223530: Route 92 Medical Full Length 070 Reperfusion System and Aspiration Tubing Set (Apr 11, 2023)
- K222743: Route 92 Medical Full Length 070 Access System (Oct 4, 2022)

Source page: https://510kreport.com/company/route-92-medical