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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 / June 2026 / K261292

510(k) cleared

PR Water-Base Lube Personal Lubricant (PR Water-Base Lube Personal Lubricant)

PR Personal Care Laboratories · Jun 11, 2026 · K261292

FDA cleared the PR Water-Base Lube Personal Lubricant (PR Water-Base Lube Personal Lubricant) from PR Personal Care Laboratories on Jun 11, 2026 under K261292, 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 Apr 20, 2026. The decision came 52 days later, inside the 90 FDA-day goal for a 510(k).

This is the only decision on file for PR Personal Care Laboratories in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K261292?

K261292 is the FDA 510(k) for PR Water-Base Lube Personal Lubricant (PR Water-Base Lube Personal Lubricant), submitted by PR Personal Care Laboratories. FDA's decision date was Jun 11, 2026, under product code NUC (Lubricant, Personal).

Who makes the PR Water-Base Lube Personal Lubricant (PR Water-Base Lube Personal Lubricant)?

PR Personal Care Laboratories, based in Valencia, CA, is the applicant of record for K261292.

How long did the K261292 review take?

FDA received the submission on Apr 20, 2026 and issued its decision on Jun 11, 2026, 52 days later.

← All decisions in June 2026