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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 / January 2026 / K252307

510(k) cleared

Getinge GSS67N Series Steam Sterilizer

Maquet GmbH (A Getinge Group Company) · Jan 22, 2026 · K252307

FDA cleared the Getinge GSS67N Series Steam Sterilizer from Maquet GmbH (A Getinge Group Company) on Jan 22, 2026 under K252307, a traditional 510(k). The device falls under product code FLE, Sterilizer, Steam, regulated at 21 CFR 880.6880 as a Class 2 device. The review panel was General Hospital.

FDA logged the submission as received on Jul 24, 2025. The decision came 182 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 Maquet GmbH (A Getinge Group Company) in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K252307?

K252307 is the FDA 510(k) for Getinge GSS67N Series Steam Sterilizer, submitted by Maquet GmbH (A Getinge Group Company). FDA's decision date was Jan 22, 2026, under product code FLE (Sterilizer, Steam).

Who makes the Getinge GSS67N Series Steam Sterilizer?

Maquet GmbH (A Getinge Group Company), based in Rastatt De-Bw, is the applicant of record for K252307.

How long did the K252307 review take?

FDA received the submission on Jul 24, 2025 and issued its decision on Jan 22, 2026, 182 days later.

← All decisions in January 2026