# K982216: Ultima Respiratory Effort Sensor Models 0520 and 0522

- Pathway: 510(k) (Traditional)
- Applicant: Braebon Medical Corp.
- Decided: Sep 11, 1998 after 80 days
- Product code: BZQ (Monitor, Breathing Frequency)
- 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.
1 later device descends from it; 1 cites it directly.
0 of 2 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
- K061764: Medibyte, Model MP8 (2006), 0 descendants of its own

## Indications for use
An indicator of respiratory effort for recording onto a data acquisition system.

Source page: https://510kreport.com/device/K982216
Methodology: https://510kreport.com/methodology