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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 / December 2025 / K251770

510(k) cleared

SleepRes PAP System

Sleepres, Inc. · Dec 15, 2025 · K251770

FDA cleared the SleepRes PAP System from Sleepres, Inc. on Dec 15, 2025 under K251770, a traditional 510(k). The device falls under product code BZD, Ventilator, Non-Continuous (Respirator), regulated at 21 CFR 868.5905 as a Class 2 device. The review panel was Anesthesiology.

FDA logged the submission as received on Jun 10, 2025. The decision came 188 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 Sleepres, Inc. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K251770?

K251770 is the FDA 510(k) for SleepRes PAP System, submitted by Sleepres, Inc.. FDA's decision date was Dec 15, 2025, under product code BZD (Ventilator, Non-Continuous (Respirator)).

Who makes the SleepRes PAP System?

Sleepres, Inc., based in Murfreesboro, TN, is the applicant of record for K251770.

How long did the K251770 review take?

FDA received the submission on Jun 10, 2025 and issued its decision on Dec 15, 2025, 188 days later.

← All decisions in December 2025