# K151758: ALAR Nasal Valve Stent

- Pathway: 510(k) (Traditional)
- Applicant: Medtronic Xomed, Inc.
- Decided: Oct 29, 2015 after 122 days
- Product code: GAT (Suture, Nonabsorbable, Synthetic, Polyethylene)
- Device class: 2
- Regulation: 21 CFR 878.5000
- 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 K930738 (1994). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K021019: Cottony II, Silky II Polydek & Tevdek II Polyester Suture, Genzyme Corp. (2002) Summary page 4.
- (no number) Medtronic Xomed Internal Nasal Splints: named in the summary without a submission number

## Indications for use
The ALAR™ Nasal Valve Stent is intended for use in supporting the lateral nasal wall during the post-operative healing period following nasal valve surgery. This procedure may be performed independently or in conjunction with other procedures such as septoplasty and turbinoplasty in order to address nasal obstruction.

Source page: https://510kreport.com/device/K151758
Methodology: https://510kreport.com/methodology