# K042253: Sleepsense Sleep Sensors

- Pathway: 510(k) (Traditional)
- Applicant: S.L.P., Ltd.
- Decided: Oct 6, 2004 after 47 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: 1 generation back to K903300 (1990). 3 ancestors in all.
4 later devices descend from it; 3 cite it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K941759: Snoring Sensor, Epm Development Systems Corp. (1994) Summary page 2.
- K922112: Easyflow, Epm Information Systems, Inc. (1992) Summary page 2.
- K903300: Resp-EZ (TM) Respiratory Monitoring Belt, Epm Information Systems, Inc. (1990) Summary page 2.
- (no number) moving images (tm): named in the summary without a submission number

## Cited in the summary but kept off the family tree
- K930303: Datascope Multinex ID Plus, Datascope Corp. (1993). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

## Most influential descendants
- K173793: XactTrace Single Use Respiratory Effort Belt System (2019), 1 descendant of its own
- K242424: Bluebird Single-Use Respiratory Effort Belt (2024), 0 descendants of its own
- K180001: Disposable BreathSensor Adult, Disposable BreathSensor Small Adult / Child, Disposable BreathSensor Preemie, Disposable BreathSensor Infant (2019), 0 descendants of its own
- K080375: RMX Physiological Data Recorder (2008), 0 descendants of its own

## Indications for use
SleepSense sleep sensors provide a qualitative measure of some physiological parameters for recording onto an FDA-cleared data acquisition system. Their target population: Children and adult patients who are screened during sleep disorder studies. Their environment of use is usually at a sleep laboratory or sometimes at the patient's home.

Source page: https://510kreport.com/device/K042253
Methodology: https://510kreport.com/methodology