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The Tracker / September 2026 / K260220

510(k) cleared

Route 92 Medical Full Length 046 Access System

Route 92 Medical, Inc. · Sep 16, 2026 · K260220 · In the directory

FDA cleared the Route 92 Medical Full Length 046 Access System from Route 92 Medical, Inc. on Sep 16, 2026 under K260220, a traditional 510(k). The device falls under product code QJP, Catheter, Percutaneous, Neurovasculature, regulated at 21 CFR 870.1250 as a Class 2 device. The review panel was Cardiovascular.

FDA logged the submission as received on Jan 26, 2026. The decision came 233 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

This is the only decision on file for Route 92 Medical, Inc. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K260220?

K260220 is the FDA 510(k) for Route 92 Medical Full Length 046 Access System, submitted by Route 92 Medical, Inc.. FDA's decision date was Sep 16, 2026, under product code QJP (Catheter, Percutaneous, Neurovasculature).

Who makes the Route 92 Medical Full Length 046 Access System?

Route 92 Medical, Inc., based in San Mateo, CA, is the applicant of record for K260220. The company is listed in the MedDevice Startups directory.

How long did the K260220 review take?

FDA received the submission on Jan 26, 2026 and issued its decision on Sep 16, 2026, 233 days later.

← All decisions in September 2026

Sources

In the startup directory

Route 92 Medical

Neurology & Neurotech · West Jordan, UT