WHERE ARE YOU?

Concept Pre-Sub Submission prep Newly cleared Raising Postmarket & security

THE TAPE

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 / K253148

510(k) cleared

RX-1 Sleep

Vivaquant, Inc. Dba Rhythm Express · Jun 22, 2026 · K253148

FDA cleared the RX-1 Sleep from Vivaquant, Inc. Dba Rhythm Express on Jun 22, 2026 under K253148, a traditional 510(k). The device falls under product code MNR, Ventilatory Effort Recorder, regulated at 21 CFR 868.2375 as a Class 2 device. The review panel was Anesthesiology.

FDA logged the submission as received on Sep 25, 2025. The decision came 270 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 Vivaquant, Inc. Dba Rhythm Express in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K253148?

K253148 is the FDA 510(k) for RX-1 Sleep, submitted by Vivaquant, Inc. Dba Rhythm Express. FDA's decision date was Jun 22, 2026, under product code MNR (Ventilatory Effort Recorder).

Who makes the RX-1 Sleep?

Vivaquant, Inc. Dba Rhythm Express, based in Arden Hills, MN, is the applicant of record for K253148.

How long did the K253148 review take?

FDA received the submission on Sep 25, 2025 and issued its decision on Jun 22, 2026, 270 days later.

← All decisions in June 2026