ROUTE 92 MEDICAL INC
FDA Regulatory Profile
ROUTE 92 MEDICAL INC appears in FDA public data with 5 recalls — including 5 Class I (most serious) —, 15 510(k) clearances, 0 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-1613-2024, Class I) was initiated on March 8, 2024. Its most recent 510(k) clearance was granted on September 16, 2026.
Summary
- Total Recalls
- 5 (5 Class I)
- 510(k) Clearances
- 15
- Inspections
- 0
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-1613-2024 | Class I | Route 92 Medical, Tenzing 7 Delivery Catheter, REF 1005, Rx Only, Sterile EO. Used for introduction | March 8, 2024 |
| Z-1614-2024 | Class I | Route 92 Medical 070 Reperfusion System, REF 1003, Rxonly, SterileEO. Used for introduction of inte | March 8, 2024 |
| Z-1610-2024 | Class I | Route 92 Medical Full Length 070 Access System, REF 7002, Rxonly, SterileEO. Used for Introduction o | March 8, 2024 |
| Z-1612-2024 | Class I | Route 92 Medical, 070 Access System, REF 1004, Rxonly , Sterile EO. Used for introduction of interv | March 8, 2024 |
| Z-1611-2024 | Class I | Route 92 Medical, Full Length 070 Reperfusion System, REF: 7001, Rxonly, SterileEO. Used for Introdu | March 8, 2024 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K260220 | Route 92 Medical Full Length 046 Access System | September 16, 2026 |
| K243601 | Route 92 Medical HiPoint Reperfusion System and Aspiration Tubing Set | May 19, 2025 |
| K240529 | 8F Modified Sheath System | October 2, 2024 |
| K233329 | Route 92 Medical Full Length 054 Reperfusion System and Aspiration Tubing Set | April 23, 2024 |
| K231583 | Route 92 Medical Full Length 054 Access System | August 15, 2023 |
| K223530 | Route 92 Medical Full Length 070 Reperfusion System and Aspiration Tubing Set | April 11, 2023 |
| K222743 | Route 92 Medical Full Length 070 Access System | October 4, 2022 |
| K210635 | Route 92 Medical Full Length 088 Access System | July 27, 2021 |
| K203043 | Route 92 Medical 070 Access System | November 11, 2020 |
| K201518 | Route 92 Medical 088 Access System | August 14, 2020 |
| K200121 | Route 92 Medical 088 Access System, 110 cm | April 18, 2020 |
| K191717 | Route 92 Medical Sheath System | January 13, 2020 |
| K190431 | Route 92 Medical Delivery Catheter | March 21, 2019 |
| K182512 | Route 92 Medical Delivery Catheter | December 10, 2018 |
| K180201 | Route 92 Medical Access System | May 23, 2018 |