Company ยท US
Spirair, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 2023 to 2026. Name variants (Inc, Corp, punctuation) are merged.
5510(k) clearances (2 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|
| NHB | Polymer, Ear, Nose And Throat, Synthetic, Absorbable | 4 |
| LYA | Splint, Intranasal Septal | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|
| Jul 30, 2026 | K260620 | SeptAlign (SPLN001) Spirair, Inc. | NHB |
| Jan 16, 2026 | K251790 | SeptAlign Spirair, Inc. | NHB |
| Jul 11, 2025 | K243655 | TurbAlign Spirair, Inc. | LYA |
| Mar 22, 2024 | K233569 | SeptAlign Spirair, Inc. | NHB |
| Aug 17, 2023 | K223167 | Spirair Nasal Septal Strap Spirair, Inc. | NHB |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|
| No recalls in this window. |