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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 / August 2026 / K261115

510(k) cleared

VR® Personal Protective Level 4 Gown (VR Gowns)

PolyConversions, Inc. · Aug 11, 2026 · K261115

FDA cleared the VR® Personal Protective Level 4 Gown (VR Gowns) from PolyConversions, Inc. on Aug 11, 2026 under K261115, 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 Apr 3, 2026. The decision came 130 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: K252940 (VR® Personal Protective Level 3 Gown (VR Gowns)).

Questions & Answers

What did FDA clear under K261115?

K261115 is the FDA 510(k) for VR® Personal Protective Level 4 Gown (VR Gowns), submitted by PolyConversions, Inc.. FDA's decision date was Aug 11, 2026, under product code QPC (Gown, Non-Sterile, Non-Isolation, Intended To Provide Moderate Or High Barrier Protection).

Who makes the VR® Personal Protective Level 4 Gown (VR Gowns)?

PolyConversions, Inc., based in Champaign, IL, is the applicant of record for K261115.

How long did the K261115 review take?

FDA received the submission on Apr 3, 2026 and issued its decision on Aug 11, 2026, 130 days later.

← All decisions in August 2026

Sources