RX-1 Sleep
FDA 510(k) K253148 · Vivaquant, Inc. Dba Rhythm Express
510(k) numberK253148
Submission
- Device name
- RX-1 Sleep
- Applicant
- Vivaquant, Inc. Dba Rhythm Express
Arden Hills, MN, US - Received
- September 25, 2025
- Decision date
- June 22, 2026
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- MNR – Ventilatory Effort Recorder
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 868.2375
- Specialty
- Anesthesiology
Other 510(k)s with product code MNR
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K254042 | WatchPAT SWMNR · Traditional | Itamar Medical , Ltd. | 07/31/2026SE |
| K260050 | WRAP SystemMNR · Traditional | Huneo, LLC | 07/15/2026SE |
| K252628 | CassieMNR · Traditional | Wesper, Inc. | 04/27/2026SE |
| K252497 | Sansa HsatMNR · Traditional | Huxley Medical | 12/10/2025SE |
| K250882 | Sansa HsatMNR · Traditional | Huxley Medical | 10/29/2025SE |
| K250460 | WatchPAT400 (WP400)MNR · Traditional | Itamar Medical , Ltd. | 09/05/2025SE |
| K252383 | Somfit DMNR · Special | Compumedics Limited | 08/28/2025SE |
| K243220 | Onera STS 2 (ONERA STS 2)MNR · Traditional | Onera B.V. | 07/03/2025SE |
| K242224 | Happy Health Home Sleep TestMNR · Traditional | Happy Health, Inc. | 06/18/2025SE |
| K243092 | AcuPebble Ox (200)MNR · Traditional | Acurable Limited | 03/19/2025SE |
Questions and answers
When was RX-1 Sleep cleared by the FDA?
RX-1 Sleep (K253148) received a 510(k) decision of Substantially Equivalent on June 22, 2026, 270 days after the submission was received.
What is the product code of K253148?
The FDA product code is MNR – Ventilatory Effort Recorder, a Class II (moderate risk) device regulated under 21 CFR 868.2375.