# K981445: Ultima Airflow Sensor, 0510

- Pathway: 510(k) (Traditional)
- Applicant: Braebon Medical Corp.
- Decided: Oct 5, 1998 after 166 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.
55 later devices descend from it; 2 cite it directly.
0 of 56 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
- K984431: Ultima Airflow Pressure Sensor (1998), 50 descendants of its own
- K031202: Medipalm-20 (2003), 48 descendants of its own
- K073682: Embletta Gold (2008), 41 descendants of its own
- K122516: Embletta MPR (2013), 27 descendants of its own
- K161579: Watch-PAT200U (2017), 20 descendants of its own

## Indications for use
A qualitative measure of respiratory airflow for recording onto a data acquisition system.

Source page: https://510kreport.com/device/K981445
Methodology: https://510kreport.com/methodology