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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 / K253939

510(k) cleared

DeltaWave Nasal Pillow System

RemSleep Holdings, Inc. · Jan 7, 2026 · K253939

FDA cleared the DeltaWave Nasal Pillow System from RemSleep Holdings, Inc. on Jan 7, 2026 under K253939, a special 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 Dec 9, 2025. The decision came 29 days later, inside the 90 FDA-day goal for a 510(k).

This is the only decision on file for RemSleep Holdings, Inc. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K253939?

K253939 is the FDA 510(k) for DeltaWave Nasal Pillow System, submitted by RemSleep Holdings, Inc.. FDA's decision date was Jan 7, 2026, under product code BZD (Ventilator, Non-Continuous (Respirator)).

Who makes the DeltaWave Nasal Pillow System?

RemSleep Holdings, Inc., based in Blackshear, GA, is the applicant of record for K253939.

How long did the K253939 review take?

FDA received the submission on Dec 9, 2025 and issued its decision on Jan 7, 2026, 29 days later.

← All decisions in January 2026