Data / Medical devices / United States / Route 92 Medical, Head Quarters

Route 92 Medical, Head Quarters: FDA-registered device maker in San Mateo, CA, United States, 10 510(k) clearances

Name: Route 92 Medical, Head Quarters FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Route 92 Medical, Head Quarters is registered with the FDA (registration 3016522967) in San Mateo, CA, United States. It lists 3 device types. The FDA files 10 510(k) clearances under its listings, the newest dated September 16, 2026. 1 recall event names it as the recalling firm (1 Class I). Registered through 2027. FDA data exported November 2, 2026.

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FDA registration number: 3016522967
Address: 155 Bovet Road Suite 100, San Mateo, CA, United States, 94402
Owner or operator: Route 92 Medical (10054934)
Roles: Complaint file establishment, Manufacturer, Repackager or relabeler
First device listed: July 11, 2019
Registered through: 2027
Brand names listed: Base Camp Sheath System 2 Berenstein 80cm, Base Camp Sheath System 2 Berenstein 90cm, FreeClimb 54 Reperfusion Catheter with Tenzing 5, FreeClimb 54 Reperfusion System, FreeClimb 70 reperfusion catheter with Tenzing 7, HiPoint reperfusion catheter with Tenzing

Devices it lists

Device	Product code	Class	Role	Source
Catheter, Percutaneous	DQY	2	Complaint file establishment, Manufacturer, Repackager or relabeler	accessdata.fda.gov
Catheter, Percutaneous, Neurovasculature	QJP	2	Complaint file establishment, Manufacturer, Repackager or relabeler	accessdata.fda.gov
Catheter, Thrombus Retriever	NRY	2	Complaint file establishment, Manufacturer, Repackager or relabeler	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
September 16, 2026	K260220	Route 92 Medical Full Length 046 Access System	QJP	Substantially Equivalent	Route 92 Medical, Inc.	accessdata.fda.gov
May 19, 2025	K243601	Route 92 Medical HiPoint Reperfusion System and Aspiration Tubing Set	NRY	Substantially Equivalent	Route 92 Medical, Inc.	accessdata.fda.gov
October 2, 2024	K240529	8F Modified Sheath System	QJP	Substantially Equivalent	Route 92 Medical, Inc.	accessdata.fda.gov
April 23, 2024	K233329	Route 92 Medical Full Length 054 Reperfusion System and Aspiration Tubing Set	NRY	Substantially Equivalent	Route 92 Medical, Inc.	accessdata.fda.gov
April 11, 2023	K223530	Route 92 Medical Full Length 070 Reperfusion System and Aspiration Tubing Set	NRY	Substantially Equivalent	Route 92 Medical, Inc.	accessdata.fda.gov
July 27, 2021	K210635	Route 92 Medical Full Length 088 Access System	QJP	Substantially Equivalent	Route 92 Medical, Inc.	accessdata.fda.gov
November 11, 2020	K203043	Route 92 Medical 070 Access System	QJP	Substantially Equivalent	Route 92 Medical, Inc.	accessdata.fda.gov
August 14, 2020	K201518	Route 92 Medical 088 Access System	QJP	Substantially Equivalent	Route 92 Medical	accessdata.fda.gov
January 13, 2020	K191717	Route 92 Medical Sheath System	DQY	Substantially Equivalent	Route 92 Medical, Inc.	accessdata.fda.gov
March 21, 2019	K190431	Route 92 Medical Delivery Catheter	DQY	Substantially Equivalent	Route 92 Medical, Inc.	accessdata.fda.gov

Recalls

Recall events where this establishment is the recalling firm, matched on its FEI.

Initiated	Event	Class	Status	Product	Reason	Source
March 8, 2024	94270	Class I	Ongoing	Route 92 Medical Full Length 070 Access System, REF 7002, Rxonly, SterileEO. Used for Introduction of interventional devices into the neurovasculature.	Their is the potential for distal tip separation at the proximal marker band of the delivery catheters.	accessdata.fda.gov

Compare with other makers

Updated September 16, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.