# K020312: Ultima Snoring Mike, Model 0540

- Pathway: 510(k) (Traditional)
- Applicant: Braebon Medical Corp.
- Decided: Aug 7, 2002 after 189 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.
25 later devices descend from it; 2 cite it directly.
0 of 26 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K102567: Watch-Pat 200S-3 (WP200S-3) (2011), 23 descendants of its own
- K133859: Watch-PAT200U (WP200U) (2014), 22 descendants of its own
- K161579: Watch-PAT200U (2017), 20 descendants of its own
- K180775: Watch-PAT300 (2018), 12 descendants of its own
- K191031: NightOwl (2020), 5 descendants of its own

## Indications for use
The Ultima Snoring Mike provides a qualitative measure of snoring for recording onto an FDA-cleared data acquisition system.

Source page: https://510kreport.com/device/K020312
Methodology: https://510kreport.com/methodology