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 / March 2026 / DEN250012

510(k) cleared

LifeVac

Lifevac, LLC · Mar 4, 2026 · DEN250012

FDA cleared the LifeVac from Lifevac, LLC on Mar 4, 2026 under DEN250012, a direct 510(k). The device falls under product code QXN, Suction Anti-Choking Device As A Second-Line Treatment, regulated at 21 CFR 874.5400 as a Class 2 device. The review panel was Ear, Nose, Throat.

FDA logged the submission as received on Apr 11, 2025. The decision came 327 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 Lifevac, LLC in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under DEN250012?

DEN250012 is the FDA 510(k) for LifeVac, submitted by Lifevac, LLC. FDA's decision date was Mar 4, 2026, under product code QXN (Suction Anti-Choking Device As A Second-Line Treatment).

Who makes the LifeVac?

Lifevac, LLC, based in Nesconset, NY, is the applicant of record for DEN250012.

How long did the DEN250012 review take?

FDA received the submission on Apr 11, 2025 and issued its decision on Mar 4, 2026, 327 days later.

← All decisions in March 2026