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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 / October 2025 / K252910

510(k) cleared

Orca Air/Water and Suction Valves

Boston Scientific · Oct 9, 2025 · K252910

FDA cleared the Orca Air/Water and Suction Valves from Boston Scientific on Oct 9, 2025 under K252910, a special 510(k). The device falls under product code ODC, Endoscope Channel Accessory, regulated at 21 CFR 876.1500 as a Class 2 device. The review panel was Gastroenterology, Urology.

FDA logged the submission as received on Sep 12, 2025. The decision came 27 days later, inside the 90 FDA-day goal for a 510(k).

Boston Scientific has 8 other decisions in the tracker over the last 12 months: K262406 (EluPro Antibiotic-Eluting BioEnvelope), K261488 (OBSIDIO Conformable Embolic), K262165 (FARADRIVE Steerable Sheath (M004PF21M402)), K262462 (TheraSphere 360 Y-90 Management Platform).

Questions & Answers

What did FDA clear under K252910?

K252910 is the FDA 510(k) for Orca Air/Water and Suction Valves, submitted by Boston Scientific. FDA's decision date was Oct 9, 2025, under product code ODC (Endoscope Channel Accessory).

Who makes the Orca Air/Water and Suction Valves?

Boston Scientific, based in Marlboro, MA, is the applicant of record for K252910.

How long did the K252910 review take?

FDA received the submission on Sep 12, 2025 and issued its decision on Oct 9, 2025, 27 days later.

← All decisions in October 2025