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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 / K251731

510(k) cleared

KARL STORZ Flexible Intubation Video Endoscope Sterile (FIVE-S) (0916612)

Karl Storz SE & CO. KG · Dec 5, 2025 · K251731

FDA cleared the KARL STORZ Flexible Intubation Video Endoscope Sterile (FIVE-S) (0916612) from Karl Storz SE & CO. KG on Dec 5, 2025 under K251731, a special 510(k). The device falls under product code EOQ, Bronchoscope (Flexible Or Rigid), regulated at 21 CFR 874.4680 as a Class 2 device. The review panel was Ear, Nose, Throat.

FDA logged the submission as received on Jun 6, 2025. The decision came 182 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Karl Storz SE & CO. KG has 8 other decisions in the tracker over the last 12 months: K261706 (Endomat Select (UP220)), K252800 (KARL STORZ Endoscopic Accessories for Urology), K252624 (KARL STORZ Laryngoscopes and Accessories), K254228 (KARL STORZ Trocars with Valve Seals).

Questions & Answers

What did FDA clear under K251731?

K251731 is the FDA 510(k) for KARL STORZ Flexible Intubation Video Endoscope Sterile (FIVE-S) (0916612), submitted by Karl Storz SE & CO. KG. FDA's decision date was Dec 5, 2025, under product code EOQ (Bronchoscope (Flexible Or Rigid)).

Who makes the KARL STORZ Flexible Intubation Video Endoscope Sterile (FIVE-S) (0916612)?

Karl Storz SE & CO. KG, based in Tuttlingen, is the applicant of record for K251731.

How long did the K251731 review take?

FDA received the submission on Jun 6, 2025 and issued its decision on Dec 5, 2025, 182 days later.

← All decisions in December 2025