# K223167: Spirair Nasal Septal Strap

- Pathway: 510(k) (Traditional)
- Applicant: Spirair, Inc.
- Decided: Aug 17, 2023 after 314 days
- Product code: NHB (Polymer, Ear, Nose And Throat, Synthetic, Absorbable)
- Device class: 2
- Regulation: 21 CFR 874.3620
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K922489 (1992). 10 ancestors in all.
3 later devices descend from it; 1 cites it directly.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K132920: Spirox Inex Device, Spirox, Inc. (2014) Summary page 4.

## Most influential descendants
- K233569: SeptAlign (2024), 2 descendants of its own
- K251790: SeptAlign (2026), 1 descendant of its own
- K260620: SeptAlign (SPLN001) (2026), 0 descendants of its own

## Indications for use
The Spirair Nasal Septal Strap is used to support and straighten minor deviations in septal cartilage when sufficient healthy cartilage exists, and the cartilage is appropriately mobilized utilizing standard septoplasty techniques.

Source page: https://510kreport.com/device/K223167
Methodology: https://510kreport.com/methodology