# K002135: Sleepstrip Disposable Apnea Screener

- Pathway: 510(k) (Traditional)
- Applicant: Influent, Ltd.
- Decided: Dec 6, 2000 after 145 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
No predicates in its family tree.
13 later devices descend from it; 3 cite it directly.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K112822: Sleepstrip II (2011), 6 descendants of its own
- K173974: Drowzle (2019), 5 descendants of its own
- K030869: Bitestrip (2004), 3 descendants of its own
- K210480: AcuPebble SA (2021), 2 descendants of its own
- K092675: Grindcare (2010), 2 descendants of its own

Source page: https://510kreport.com/device/K002135
Methodology: https://510kreport.com/methodology