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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 / April 2026 / K252471

510(k) cleared

Paptizer 360

LiViliti Health Products Corporation · Apr 29, 2026 · K252471

FDA cleared the Paptizer 360 from LiViliti Health Products Corporation on Apr 29, 2026 under K252471, a traditional 510(k). The device falls under product code QXQ, Respiratory Accessory Microbial Reduction Device., regulated at 21 CFR 880.6993 as a Class 2 device. The review panel was General Hospital.

FDA logged the submission as received on Aug 6, 2025. The decision came 266 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 LiViliti Health Products Corporation in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K252471?

K252471 is the FDA 510(k) for Paptizer 360, submitted by LiViliti Health Products Corporation. FDA's decision date was Apr 29, 2026, under product code QXQ (Respiratory Accessory Microbial Reduction Device.).

Who makes the Paptizer 360?

LiViliti Health Products Corporation, based in Lake City, FL, is the applicant of record for K252471.

How long did the K252471 review take?

FDA received the submission on Aug 6, 2025 and issued its decision on Apr 29, 2026, 266 days later.

← All decisions in April 2026