# K233569: SeptAlign

- Pathway: 510(k) (Traditional)
- Applicant: Spirair, Inc.
- Decided: Mar 22, 2024 after 137 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: 4 generations back to K922489 (1992). 11 ancestors in all.
2 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)
- K223167: Spirair Nasal Septal Strap, Spirair, Inc. (2023) Summary page 4.

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

## Indications for use
SeptAlign 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/K233569
Methodology: https://510kreport.com/methodology