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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 / January 2026 / K252984

510(k) cleared

Perin Health System (PHD80060-2)

Perin Health Devices, LLC · Jan 22, 2026 · K252984

FDA cleared the Perin Health System (PHD80060-2) from Perin Health Devices, LLC on Jan 22, 2026 under K252984, a traditional 510(k). The device falls under product code DRG, Transmitters And Receivers, Physiological Signal, Radiofrequency, regulated at 21 CFR 870.2910 as a Class 2 device. The review panel was Cardiovascular.

FDA logged the submission as received on Sep 18, 2025. The decision came 126 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 Perin Health Devices, LLC in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K252984?

K252984 is the FDA 510(k) for Perin Health System (PHD80060-2), submitted by Perin Health Devices, LLC. FDA's decision date was Jan 22, 2026, under product code DRG (Transmitters And Receivers, Physiological Signal, Radiofrequency).

Who makes the Perin Health System (PHD80060-2)?

Perin Health Devices, LLC, based in Oklahoma City, OK, is the applicant of record for K252984.

How long did the K252984 review take?

FDA received the submission on Sep 18, 2025 and issued its decision on Jan 22, 2026, 126 days later.

← All decisions in January 2026