# K012437: Devilbiss Sleep Recorder Model # RM60

- Pathway: 510(k) (Traditional)
- Applicant: Sunrise Medical Hhg, Inc.
- Decided: Jul 16, 2002 after 350 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: 2 generations back to K930790 (1994). 4 ancestors in all.
42 later devices descend from it; 2 cite it directly.
0 of 47 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K962103: Bio-Logic Sleepscan Product with Built-in Oximeter, Bio-Logic Systems Corp. (1996) Summary page 1.
- K934599: Sandman, Melville Software, Ltd. (1994) Summary page 1.

## Most influential descendants
- K040595: ALICE 5 (2004), 40 descendants of its own
- K112102: Michele Sleep Scoring Systems (2011), 18 descendants of its own
- K120450: Sleep Profiler (2012), 16 descendants of its own
- K130007: Sleep Profiler (2013), 14 descendants of its own
- K153412: Sleep Profiler (2016), 13 descendants of its own

## Indications for use
The DeVilbiss Sleep Recorder is intended for screening patients suspected of or exhibiting symptoms of sleep disorders. The DeVilbiss Sleep Recorder can be used with an autotitrating CPAP to record the results of CPAP treatment for adults diagnosed with sleep apnea syndrome. Patients suffering from excessive daytime sleepiness should be referred to a sleep disorder specialist. The results of an unattended screening are insufficient to identify all possible medical disorders that may produce these symptoms. This device is intended to aid the physician in diagnosing adult sleep apnea. A qualified medical professional should score the device’s recorded signals to determine respiratory events.

Source page: https://510kreport.com/device/K012437
Methodology: https://510kreport.com/methodology