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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 / March 2026 / K252208

510(k) cleared

JFord Speculum Sleeve

Ford Medtech, LLC · Mar 6, 2026 · K252208

FDA cleared the JFord Speculum Sleeve from Ford Medtech, LLC on Mar 6, 2026 under K252208, a traditional 510(k). The device falls under product code HIB, Speculum, Vaginal, Nonmetal, regulated at 21 CFR 884.4530 as a Class 2 device. The review panel was Obstetrics/Gynecology.

FDA logged the submission as received on Jul 15, 2025. The decision came 234 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

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

Questions & Answers

What did FDA clear under K252208?

K252208 is the FDA 510(k) for JFord Speculum Sleeve, submitted by Ford Medtech, LLC. FDA's decision date was Mar 6, 2026, under product code HIB (Speculum, Vaginal, Nonmetal).

Who makes the JFord Speculum Sleeve?

Ford Medtech, LLC, based in Westbury, NY, is the applicant of record for K252208.

How long did the K252208 review take?

FDA received the submission on Jul 15, 2025 and issued its decision on Mar 6, 2026, 234 days later.

← All decisions in March 2026