# K972082: Custom Nasal Splint

- Pathway: 510(k) (Traditional)
- Applicant: Boston Medical Products, Inc.
- Decided: Jul 3, 1997 after 29 days
- Product code: LYA (Splint, Intranasal Septal)
- Device class: 1
- Regulation: 21 CFR 874.4780
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
48 later devices descend from it; 1 cites it directly.
0 of 49 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Product Nos. 20-10670, 20-10675, 20-10685, 20-10682, 20-10680, and 20-10686 manufactured by Invotec International, Inc.: named in the summary without a submission number

## Most influential descendants
- K012532: Sepragel Sinus (2001), 47 descendants of its own
- K033666: Hemaderm (2003), 29 descendants of its own
- K070211: Traumarrest and Bleedarrest Hemostatic Particles and Foam (2007), 28 descendants of its own
- K072900: Excelarrest  Foam (2007), 19 descendants of its own
- K052099: Nasopore Nasal Dressing, Model Ndox-Yyy/ZZ (2005), 17 descendants of its own

## Indications for use
To provide septal support and reduce or prevent adhesions between the septum and lateral nasal wall following surgery.

Source page: https://510kreport.com/device/K972082
Methodology: https://510kreport.com/methodology