# LYA: Splint, Intranasal Septal

- Device class: 1; regulation: 21 CFR 874.4780; FDA's rule: 510(k) exempt
- FDA decisions: 46
- 510(k) review time 2021–2025: median 63 days (middle half 46–145)
- Recalls: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026; MAUDE to Sep 30, 2026

## Decisions per year (last 10)
- 2012: 1
- 2013: 2
- 2014: 5
- 2016: 1
- 2017: 2
- 2018: 2
- 2020: 1
- 2021: 1
- 2023: 1
- 2025: 1

## Most-cited predicates
- K052099: Nasopore Nasal Dressing, Model Ndox-Yyy/ZZ (2005), cited by 10
- K041381: Meropack Bioresorbable Nasal Packing and Sinus Stent (2004), cited by 8
- K012532: Sepragel Sinus (2001), cited by 6
- K113585: Nasal/Epistaxis Pack (2012), cited by 3
- K002131: Lactosorb Ethmoid Stent (2001), cited by 3
- K122494: Posisep and Posisep X Hemostat Dressing/Intranasal Splint (2013), cited by 2
- K082276: Synthemed Device (2008), cited by 2
- K070496: Advacoat Sinus Gel and Stent (2007), cited by 2
- K972096: Bivalve Nasal Splint (1997), cited by 1
- K180141: SPIWay Endonasal Access Guide (2018), cited by 1

Source page: https://510kreport.com/product-code/LYA
Data by year (CSV): https://510kreport.com/product-code/LYA.csv