Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Spirair, Inc. — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
219 daysmedian FDA review time
314 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K260620 | SeptAlign (SPLN001) | Spirair, Inc. | 2026-07-30 | 155 | 0 |
| K251790 | SeptAlign | Spirair, Inc. | 2026-01-16 | 219 | 0 |
| K243655 | TurbAlign | Spirair, Inc. | 2025-07-11 | 227 | 0 |
| K233569 | SeptAlign | Spirair, Inc. | 2024-03-22 | 137 | 0 |
| K223167 | Spirair Nasal Septal Strap | Spirair, Inc. | 2023-08-17 | 314 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda