Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Spire Medical, Inc. · Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
22 daysmedian FDA review time
45 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K821487 | MICRO-SURGICAL POWER INSTRUMENT SYS. | Spire Medical, Inc. | 1982-07-02 | 45 | 0 |
| K821485 | DERMABRADERS | Spire Medical, Inc. | 1982-06-10 | 23 | 0 |
| K821486 | MICRO DRILLS | Spire Medical, Inc. | 1982-06-09 | 22 | 0 |
| K802463 | MICRO-SURGICAL POWER INSTRUMENT SYSTEM | Spire Medical, Inc. | 1980-10-31 | 22 | 0 |
| K802503 | MICRO-SUGICAL POWER INSTRUMENT SYSTEM | Spire Medical, Inc. | 1980-10-31 | 14 | 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