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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 / May 2026 / K260725

510(k) cleared

BAÜMER Surgical Gowns (COP01, COP04, COP05, COP10)

Hindernis DE Mexico, S.A.P.I. DE C.V. · May 12, 2026 · K260725

FDA cleared the BAÜMER Surgical Gowns (COP01, COP04, COP05, COP10) from Hindernis DE Mexico, S.A.P.I. DE C.V. on May 12, 2026 under K260725, a traditional 510(k). The device falls under product code FYA, Gown, Surgical, 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 Mar 5, 2026. The decision came 68 days later, inside the 90 FDA-day goal for a 510(k).

This is the only decision on file for Hindernis DE Mexico, S.A.P.I. DE C.V. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K260725?

K260725 is the FDA 510(k) for BAÜMER Surgical Gowns (COP01, COP04, COP05, COP10), submitted by Hindernis DE Mexico, S.A.P.I. DE C.V.. FDA's decision date was May 12, 2026, under product code FYA (Gown, Surgical).

Who makes the BAÜMER Surgical Gowns (COP01, COP04, COP05, COP10)?

Hindernis DE Mexico, S.A.P.I. DE C.V., based in Naucalpan De Juarez, is the applicant of record for K260725.

How long did the K260725 review take?

FDA received the submission on Mar 5, 2026 and issued its decision on May 12, 2026, 68 days later.

← All decisions in May 2026