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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 / August 2026 / K261905

510(k) cleared

BUM Oil

Bumlicious, LLC (DBA Bumlicious) · Aug 7, 2026 · K261905

FDA cleared the BUM Oil from Bumlicious, LLC (DBA Bumlicious) on Aug 7, 2026 under K261905, a traditional 510(k). The device falls under product code NUC, Lubricant, Personal, regulated at 21 CFR 884.5300 as a Class 2 device. The review panel was Obstetrics/Gynecology.

FDA logged the submission as received on Jun 8, 2026. The decision came 60 days later, inside the 90 FDA-day goal for a 510(k).

This is the only decision on file for Bumlicious, LLC (DBA Bumlicious) in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K261905?

K261905 is the FDA 510(k) for BUM Oil, submitted by Bumlicious, LLC (DBA Bumlicious). FDA's decision date was Aug 7, 2026, under product code NUC (Lubricant, Personal).

Who makes the BUM Oil?

Bumlicious, LLC (DBA Bumlicious), based in Fort Lauderdale, FL, is the applicant of record for K261905.

How long did the K261905 review take?

FDA received the submission on Jun 8, 2026 and issued its decision on Aug 7, 2026, 60 days later.

← All decisions in August 2026