FDA product code LYA: Splint, Intranasal Septal
LYA is the FDA product code for splint, intranasal septal. It is a Class I device, regulated under 21 CFR 874.4780 and reviewed by the Ear, Nose and Throat panel. FDA has cleared 46 510(k) submissions under LYA, 2 in the last five years, from 33 different applicants. The average 510(k) review took 96 days (median 88); 227 days on average over the last three years. FDA has posted 2 recalls for LYA devices, 1 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Splint, Intranasal Septal |
| Device class | Class I |
| Regulation | 21 CFR 874.4780 |
| Review panel | EN — Ear, Nose and Throat |
| Medical specialty | Ear, Nose, Throat |
| Premarket route | 510(k) exempt |
510(k) clearances per year for LYA
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 2 | 176 |
| 2018 | 2 | 92 |
| 2020 | 1 | 89 |
| 2021 | 1 | 29 |
| 2023 | 1 | 63 |
| 2025 | 1 | 227 |
Compare with all 510(k) review times · Search every LYA clearance
Top LYA applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Spiway, LLC | 4 | 2021-10-27 |
| Boston Medical Products, Inc. | 4 | 1997-07-15 |
| Polyganics B.V., | 3 | 2014-10-23 |
| Smith & Nephew Richards, Inc. | 3 | 1995-06-07 |
| Carbylan Biosurgery | 2 | 2007-03-15 |
28 more applicants have LYA clearances. See the full list in Caduvo.
Most recent LYA clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K243655 | Spirair, Inc. | TurbAlign | 2025-07-11 | 227 |
| K230142 | Biomed Ent, Inc. | Epi-Stop Nasal Gel/epistaxis pack | 2023-03-22 | 63 |
| K213153 | Spiway, LLC | SPIWay Endonasal Access Guide | 2021-10-27 | 29 |
| K202623 | Medtronic Xomed | Novapak Nasal Sinus Packing and Stent | 2020-12-08 | 89 |
| K181696 | Gyrus Acmi, Inc. | ChitoZolve | 2018-11-30 | 156 |
Recalls for LYA devices
2 product recalls in 2 recall events; 1 initiated in the last five years and 0 still open. Most recent: 2022-07-27.
| Year | Recalls |
|---|---|
| 2022 | 1 |
Frequently asked questions
What is FDA product code LYA?
LYA is the FDA product code for splint, intranasal septal. It is a Class I device, regulated under 21 CFR 874.4780 and reviewed by the Ear, Nose and Throat panel.
What device class is LYA?
Class I, regulation 21 CFR 874.4780. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code LYA?
Across 46 cleared submissions the average was 96 days from receipt to decision (median 88).
Which companies have the most LYA clearances?
Spiway, LLC (4); Boston Medical Products, Inc. (4); Polyganics B.V., (3); Smith & Nephew Richards, Inc. (3); Carbylan Biosurgery (2).
Have LYA devices been recalled?
Yes: 2 product recalls across 2 recall events; the most recent began 2022-07-27.
Next steps
- Run an FDA pathway report with predicate devices for product code LYA
- Run a recall and safety report across every LYA manufacturer
- Watch product code LYA for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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