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FDA posts two worked PCCP examples for machine learning devices Haemonetics wins FDA approval for a patch that seals 26F arteriotomies FDA adds Olympus enteroscopes and capsule systems to Import Alert 89-04 Nova Biomedical pulls Gen 2.0 StatStrip glucose meters over stale barcode scans AdvaMed plans industry cybersecurity standards written like a code of ethics Solventum clears its Restrata matrix for use under V.A.C. negative pressure therapy Medtronic takes a CE mark for five conduction system pacing pacemakers Empyrean submits a 510(k) for Vektra, its robotic brachytherapy system Paradromics hands Siemens Healthineers the imaging workup for its brain implant FDA posts two worked PCCP examples for machine learning devices Haemonetics wins FDA approval for a patch that seals 26F arteriotomies FDA adds Olympus enteroscopes and capsule systems to Import Alert 89-04 Nova Biomedical pulls Gen 2.0 StatStrip glucose meters over stale barcode scans AdvaMed plans industry cybersecurity standards written like a code of ethics Solventum clears its Restrata matrix for use under V.A.C. negative pressure therapy Medtronic takes a CE mark for five conduction system pacing pacemakers Empyrean submits a 510(k) for Vektra, its robotic brachytherapy system Paradromics hands Siemens Healthineers the imaging workup for its brain implant

The Tracker / October 2026 / K263266

510(k) cleared

Route 92 Medical Full Length 046 Reperfusion System and Aspiration Tubing Set

Route 92 Medical, Inc. · Oct 16, 2026 · K263266 · In the directory

FDA cleared the Route 92 Medical Full Length 046 Reperfusion System and Aspiration Tubing Set from Route 92 Medical, Inc. on Oct 16, 2026 under K263266, a special 510(k). The device falls under product code NRY, Catheter, Thrombus Retriever, regulated at 21 CFR 870.1250 as a Class 2 device. The review panel was Cardiovascular.

FDA logged the submission as received on Sep 18, 2026. The decision came 28 days later, inside the 90 FDA-day goal for a 510(k).

Route 92 Medical, Inc. has one other decision in the tracker over the last 12 months: K260220 (Route 92 Medical Full Length 046 Access System).

Questions & Answers

What did FDA clear under K263266?

K263266 is the FDA 510(k) for Route 92 Medical Full Length 046 Reperfusion System and Aspiration Tubing Set, submitted by Route 92 Medical, Inc.. FDA's decision date was Oct 16, 2026, under product code NRY (Catheter, Thrombus Retriever).

Who makes the Route 92 Medical Full Length 046 Reperfusion System and Aspiration Tubing Set?

Route 92 Medical, Inc., based in San Mateo, CA, is the applicant of record for K263266. The company is listed in the MedDevice Startups directory.

How long did the K263266 review take?

FDA received the submission on Sep 18, 2026 and issued its decision on Oct 16, 2026, 28 days later.

← All decisions in October 2026

Sources

In the startup directory

Route 92 Medical

Neurology & Neurotech · West Jordan, UT