WHERE ARE YOU?

Concept Pre-Sub Submission prep Newly cleared Raising Postmarket & security

THE TAPE

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 / K252624

510(k) cleared

KARL STORZ Laryngoscopes and Accessories

KARL STORZ Endoscopy-America, Inc. · May 15, 2026 · K252624

FDA cleared the KARL STORZ Laryngoscopes and Accessories from KARL STORZ Endoscopy-America, Inc. on May 15, 2026 under K252624, a traditional 510(k). The device falls under product code EQN, Laryngoscope, Nasopharyngoscope, regulated at 21 CFR 874.4760 as a Class 2 device. The review panel was Ear, Nose, Throat.

FDA logged the submission as received on Aug 18, 2025. The decision came 270 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

KARL STORZ Endoscopy-America, Inc. has 8 other decisions in the tracker over the last 12 months: K261706 (Endomat Select (UP220)), K252800 (KARL STORZ Endoscopic Accessories for Urology), K254228 (KARL STORZ Trocars with Valve Seals), K260003 (KARL STORZ Mediastinoscopes and Instruments).

Questions & Answers

What did FDA clear under K252624?

K252624 is the FDA 510(k) for KARL STORZ Laryngoscopes and Accessories, submitted by KARL STORZ Endoscopy-America, Inc.. FDA's decision date was May 15, 2026, under product code EQN (Laryngoscope, Nasopharyngoscope).

Who makes the KARL STORZ Laryngoscopes and Accessories?

KARL STORZ Endoscopy-America, Inc., based in El Segundo, CA, is the applicant of record for K252624.

How long did the K252624 review take?

FDA received the submission on Aug 18, 2025 and issued its decision on May 15, 2026, 270 days later.

← All decisions in May 2026