Spirair, Inc.: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Spirair, Inc.” (first 2023, latest 2026), across 2 product codes in 1 review panel. Median 510(k) review time under this name: 219 days. Since 2017 the median was 219 days, against 155 days for all cleared 510(k)s in the same product codes. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2023 | 1 | 314 |
| 2024 | 1 | 137 |
| 2025 | 1 | 227 |
| 2026 | 2 | 187 |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Spirair, Inc. took a median 219 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 155 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| NHB | Polymer, Ear, Nose And Throat, Synthetic, Absorbable | 4 | 4 |
| LYA | Splint, Intranasal Septal | 1 | 1 |
Review panels
Most recent Spirair, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K260620 | SeptAlign (SPLN001) | NHB | 2026-07-30 | 155 |
| K251790 | SeptAlign | NHB | 2026-01-16 | 219 |
| K243655 | TurbAlign | LYA | 2025-07-11 | 227 |
| K233569 | SeptAlign | NHB | 2024-03-22 | 137 |
| K223167 | Spirair Nasal Septal Strap | NHB | 2023-08-17 | 314 |
Recalls
openFDA lists no recalls under a recalling firm named Spirair, Inc..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Device clinical trials
An industry sponsor named Spirair, Inc. is the lead sponsor of 3 device studies on ClinicalTrials.gov (2 active or recruiting). Most recent:
- NCT07027267: Safety and Effectiveness of TurbAlign™ for Middle Turbinate Medialization After Functional Endoscopic Sinus Surgery (Active not recruiting, started 2025-08-04)
- NCT06163404: Open-Label Study to Evaluate the Safety and Effectiveness of the Spirair Implant (Active not recruiting, started 2023-11-01)
- NCT05967169: EFS of Bioabsorbable Implant for NSD (Completed, started 2022-05-25)
Frequently asked questions
How many FDA 510(k) clearances are listed under Spirair, Inc.?
FDA lists 5 510(k) clearances under the applicant name “Spirair, Inc.” (first 2023, latest 2026), across 2 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Spirair, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Spirair, Inc. is 219 days. Since 2017: 219 days, versus 155 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Spirair, Inc.?
The most frequent FDA product codes under this applicant name are NHB (Polymer, Ear, Nose And Throat, Synthetic, Absorbable, 4); LYA (Splint, Intranasal Septal, 1).
Next steps
- See all 5 Spirair, Inc. clearances with predicates and recalls
- Run predicate analysis for product code NHB, Spirair, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.