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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 / December 2025 / K252940

510(k) cleared

VR® Personal Protective Level 3 Gown (VR Gowns)

PolyConversions, Inc. · Dec 16, 2025 · K252940

FDA cleared the VR® Personal Protective Level 3 Gown (VR Gowns) from PolyConversions, Inc. on Dec 16, 2025 under K252940, a traditional 510(k). The device falls under product code QPC, Gown, Non-Sterile, Non-Isolation, Intended To Provide Moderate Or High Barrier Protection, regulated at 21 CFR 878.4040 as a Class 2 device. The review panel was General, Plastic Surgery.

FDA logged the submission as received on Sep 15, 2025. The decision came 92 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

PolyConversions, Inc. has one other decision in the tracker over the last 12 months: K261115 (VR® Personal Protective Level 4 Gown (VR Gowns)).

Questions & Answers

What did FDA clear under K252940?

K252940 is the FDA 510(k) for VR® Personal Protective Level 3 Gown (VR Gowns), submitted by PolyConversions, Inc.. FDA's decision date was Dec 16, 2025, under product code QPC (Gown, Non-Sterile, Non-Isolation, Intended To Provide Moderate Or High Barrier Protection).

Who makes the VR® Personal Protective Level 3 Gown (VR Gowns)?

PolyConversions, Inc., based in Champaign, IL, is the applicant of record for K252940.

How long did the K252940 review take?

FDA received the submission on Sep 15, 2025 and issued its decision on Dec 16, 2025, 92 days later.

← All decisions in December 2025

Sources