# K221892: Visionair

- Pathway: 510(k) (Traditional)
- Applicant: Pacificmd Biotech, LLC
- Decided: Oct 5, 2022 after 98 days
- Product code: BXQ (Rhinoanemometer (Measurement Of Nasal Decongestion))
- Device class: 2
- Regulation: 21 CFR 868.1800
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K921452 (1993). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K170071: SGS ECCOVISIONTM Pharyngometer, SGS ECCOVISIONTM Rhinometer, SGS ECCOVISIONTM Rhino/Pharyngometer, Sleep Group Solutions (2017) Summary page 5.

## Indications for use
The VISIONAIR™ system is a software application intended to be used with third-party endoscopic systems in the measurement of the nasal respiratory airway. The VISIONAIR™ system measures the nasal respiratory airway from the endoscopic images taken in the region of the internal nasal valve (INV) and nasal cavum (NC).

Source page: https://510kreport.com/device/K221892
Methodology: https://510kreport.com/methodology