Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Microaire Surgical Instruments — Predicate Candidate Screening
3 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K223406 | SmartRelease Endoscopic Soft Tissue Release System | Microaire Surgical Instruments | 2023-02-02 | 85 | 1 |
| K211297 | SMARTRELEASE Endoscopic Soft Tissue Release System | Microaire Surgical Instruments | 2021-06-24 | 57 | 0 |
| K192694 | PAL Single-Use Cannulas | Microaire Surgical Instruments | 2020-05-14 | 231 | 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