Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Microaire Surgical Instruments, Inc. — Predicate Candidate Screening
4 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K014060 | MICROAIRE 1000E SYSTEM | Microaire Surgical Instruments, Inc. | 2002-03-05 | 85 | 0 |
| K981922 | LIGHT DUTY PNEUMATIC INSTRUMENT MODEL NUMBER PAD-100, HEAVY | Microaire Surgical Instruments, Inc. | 1998-12-10 | 192 | 0 |
| K973268 | MICROAIRE POWER ASPIRATION DEVICE PAD SYSTEM | Microaire Surgical Instruments, Inc. | 1997-11-26 | 89 | 0 |
| K955591 | MICROAIRE SMARTDRIVE SYSTEM | Microaire Surgical Instruments, Inc. | 1996-01-18 | 42 | 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