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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 / July 2026 / K261587

510(k) cleared

Insufflation Retention Device (IRD) (11173-325-101)

BPEndo, LLC · Jul 2, 2026 · K261587

FDA cleared the Insufflation Retention Device (IRD) (11173-325-101) from BPEndo, LLC on Jul 2, 2026 under K261587, a special 510(k). The device falls under product code FDF, Colonoscope And Accessories, Flexible/Rigid, regulated at 21 CFR 876.1500 as a Class 2 device. The review panel was Gastroenterology, Urology.

FDA logged the submission as received on May 13, 2026. The decision came 50 days later, inside the 90 FDA-day goal for a 510(k).

This is the only decision on file for BPEndo, LLC in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K261587?

K261587 is the FDA 510(k) for Insufflation Retention Device (IRD) (11173-325-101), submitted by BPEndo, LLC. FDA's decision date was Jul 2, 2026, under product code FDF (Colonoscope And Accessories, Flexible/Rigid).

Who makes the Insufflation Retention Device (IRD) (11173-325-101)?

BPEndo, LLC, based in Norman, OK, is the applicant of record for K261587.

How long did the K261587 review take?

FDA received the submission on May 13, 2026 and issued its decision on Jul 2, 2026, 50 days later.

← All decisions in July 2026