WHERE ARE YOU?

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

THE TAPE

Elucid raises $55M Series D with FFR-CT 510(k) under FDA review Enovis to buy eCential Robotics for 155 million euros FDA authorizes Vitestro's Aletta, the first autonomous blood-drawing robot, five months after a $70M Series B Renata Medical raises $25M Series D to scale the Minima pediatric stent FDA opens a docket on how to regulate generative AI devices FDA clears Jupiter Endovascular's Vertex thrombectomy system for pulmonary embolism in 89 days FDA clears Wandercraft's Eve, the first self-balancing exoskeleton for home use Meduloc raises $4M Series B to start alpha launch of its nitinol fracture implant FDA sets FY2027 device user fees: $28,653 for a 510(k), $13,785 to register Elucid raises $55M Series D with FFR-CT 510(k) under FDA review Enovis to buy eCential Robotics for 155 million euros FDA authorizes Vitestro's Aletta, the first autonomous blood-drawing robot, five months after a $70M Series B Renata Medical raises $25M Series D to scale the Minima pediatric stent FDA opens a docket on how to regulate generative AI devices FDA clears Jupiter Endovascular's Vertex thrombectomy system for pulmonary embolism in 89 days FDA clears Wandercraft's Eve, the first self-balancing exoskeleton for home use Meduloc raises $4M Series B to start alpha launch of its nitinol fracture implant FDA sets FY2027 device user fees: $28,653 for a 510(k), $13,785 to register

The Tracker / July 2026 / K261633

510(k) cleared

VisuBreath

Affirm Medical Technologies II, LLC · Jul 14, 2026 · K261633

FDA cleared the VisuBreath from Affirm Medical Technologies II, LLC on Jul 14, 2026 under K261633, a traditional 510(k). The device falls under product code CCK, Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase, regulated at 21 CFR 868.1400 as a Class 2 device. The review panel was Anesthesiology.

FDA logged the submission as received on May 18, 2026. The decision came 57 days later, inside the 90 FDA-day goal for a 510(k).

This is the only decision on file for Affirm Medical Technologies II, LLC in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K261633?

K261633 is the FDA 510(k) for VisuBreath, submitted by Affirm Medical Technologies II, LLC. FDA's decision date was Jul 14, 2026, under product code CCK (Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase).

Who makes the VisuBreath?

Affirm Medical Technologies II, LLC, based in Piedmont, CA, is the applicant of record for K261633.

How long did the K261633 review take?

FDA received the submission on May 18, 2026 and issued its decision on Jul 14, 2026, 57 days later.

← All decisions in July 2026