# K010649: Exhale Doppler System

- Pathway: 510(k) (Traditional)
- Applicant: Broncus Technologies, Inc.
- Decided: Mar 20, 2001 after 15 days
- Product code: IYN (System, Imaging, Pulsed Doppler, Ultrasonic)
- Device class: 2
- Regulation: 21 CFR 892.1550
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
2 later devices descend from it; 2 cite it directly.
0 of 3 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
- K090743: Yield Mini Doppler System (2009), 0 descendants of its own
- K013111: Exhale Probe (2001), 0 descendants of its own

Source page: https://510kreport.com/device/K010649
Methodology: https://510kreport.com/methodology