# K080375: RMX Physiological Data Recorder

- Pathway: 510(k) (Traditional)
- Applicant: S.L.P., Ltd.
- Decided: Sep 2, 2008 after 203 days
- Product code: MNR (Ventilatory Effort Recorder)
- Device class: 2
- Regulation: 21 CFR 868.2375
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K962603 (1997). 24 ancestors in all.
No later device cites it as a predicate yet.
0 of 25 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K033402: Portable Sleep Data Recorder (PSDR), Pro-Tech Services, Inc. (2004) Summary page 3.
- K012437: Devilbiss Sleep Recorder Model # RM60, Sunrise Medical Hhg, Inc. (2002) Summary page 3.
- K042253: Sleepsense Sleep Sensors, S.L.P., Ltd. (2004) Summary page 3.
- K040178: Pulseox 5500 Finger Device, Pulseox 7500 Wristwatch Device, S.P.O. Medical Equipment, Ltd. (2004) Summary page 3.

## Indications for use
The RMX is a physiological data recorder intended to collect and record data from multiple physiological channels and additional auxiliary inputs from undesignated channels. It is indicated for use by or on order of a physician. The RMX is intended for use in a supervised (hospital) or unsupervised (home) environment.

Source page: https://510kreport.com/device/K080375
Methodology: https://510kreport.com/methodology