WHERE ARE YOU?

Concept Pre-Sub Submission prep Newly cleared Raising Exit Postmarket & security

THE TAPE

Medtronic pays about $700M for rights to sell Cornerstone Robotics' Sentire outside the US Globus Medical wins a CE mark for Excelsius3D five years after FDA clearance GE HealthCare software updates dropped patients from monitoring, now a Class II recall Boston Scientific pulls Imager II catheters over degrading tips and ends the product line MiniMed wins a CE mark for the Flex insulin pump ahead of its year-end target Boston Scientific restarts shipping a week after the August 25 cyberattack ArthroTAK gets a second 510(k), adding knee tenodesis to its sutureless tendon anchor Oura files S-1 for Nasdaq IPO with $1.21B in nine-month revenue and 5 million paid members FDA confirms a Class I recall of Boston Scientific Infinion CX leads after 1,081 serious injuries Medtronic pays about $700M for rights to sell Cornerstone Robotics' Sentire outside the US Globus Medical wins a CE mark for Excelsius3D five years after FDA clearance GE HealthCare software updates dropped patients from monitoring, now a Class II recall Boston Scientific pulls Imager II catheters over degrading tips and ends the product line MiniMed wins a CE mark for the Flex insulin pump ahead of its year-end target Boston Scientific restarts shipping a week after the August 25 cyberattack ArthroTAK gets a second 510(k), adding knee tenodesis to its sutureless tendon anchor Oura files S-1 for Nasdaq IPO with $1.21B in nine-month revenue and 5 million paid members FDA confirms a Class I recall of Boston Scientific Infinion CX leads after 1,081 serious injuries

The Tracker / August 2026 / K261176

510(k) cleared

Zoom 4S Catheter

Imperative Care, Inc. · Aug 28, 2026 · K261176

FDA cleared the Zoom 4S Catheter from Imperative Care, Inc. on Aug 28, 2026 under K261176, 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 Apr 10, 2026. The decision came 140 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Imperative Care, Inc. has one other decision in the tracker over the last 12 months: K252046 (Zoom System (Zoom 4S Catheter)).

Questions & Answers

What did FDA clear under K261176?

K261176 is the FDA 510(k) for Zoom 4S Catheter, submitted by Imperative Care, Inc.. FDA's decision date was Aug 28, 2026, under product code QJP (Catheter, Percutaneous, Neurovasculature).

Who makes the Zoom 4S Catheter?

Imperative Care, Inc., based in Campbell, CA, is the applicant of record for K261176.

How long did the K261176 review take?

FDA received the submission on Apr 10, 2026 and issued its decision on Aug 28, 2026, 140 days later.

← All decisions in August 2026

Sources