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GE HealthCare clears aortic stenosis and lung scanning software for Vscan Air FDA draws more than 500 comments on its generative AI device framework BRIJ Medical upsizes a $3M raise to $5M for its incision management line Globus Medical bought Synaptive Medical out of receivership in August Philips sets aside 288 million euros for a proposed DOJ settlement over its CPAP recall Rockwell Medical agrees to buy most of Vantive's hemodialysis business Blackstone puts $455M into Boston Scientific's VITALYST heart pump program 1nhaler raises £2.2M to take a cardboard inhaler into the clinic ONWARD Medical sold 88 ARC-EX systems in the third quarter GE HealthCare clears aortic stenosis and lung scanning software for Vscan Air FDA draws more than 500 comments on its generative AI device framework BRIJ Medical upsizes a $3M raise to $5M for its incision management line Globus Medical bought Synaptive Medical out of receivership in August Philips sets aside 288 million euros for a proposed DOJ settlement over its CPAP recall Rockwell Medical agrees to buy most of Vantive's hemodialysis business Blackstone puts $455M into Boston Scientific's VITALYST heart pump program 1nhaler raises £2.2M to take a cardboard inhaler into the clinic ONWARD Medical sold 88 ARC-EX systems in the third quarter

The Tracker / October 2026 / K262021

510(k) cleared

Toro 71 Aspiration Catheter; Toro Aspiration Tubing

Toro Neurovascular, Inc. · Oct 21, 2026 · K262021

FDA cleared the Toro 71 Aspiration Catheter; Toro Aspiration Tubing from Toro Neurovascular, Inc. on Oct 21, 2026 under K262021, a traditional 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 Jun 16, 2026. The decision came 127 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Toro Neurovascular, Inc. has one other decision in the tracker over the last 12 months: K252297 (Toro 88 Superbore Catheter).

Questions & Answers

What did FDA clear under K262021?

K262021 is the FDA 510(k) for Toro 71 Aspiration Catheter; Toro Aspiration Tubing, submitted by Toro Neurovascular, Inc.. FDA's decision date was Oct 21, 2026, under product code NRY (Catheter, Thrombus Retriever).

Who makes the Toro 71 Aspiration Catheter; Toro Aspiration Tubing?

Toro Neurovascular, Inc., based in Irvine, CA, is the applicant of record for K262021.

How long did the K262021 review take?

FDA received the submission on Jun 16, 2026 and issued its decision on Oct 21, 2026, 127 days later.

← All decisions in October 2026

Sources