Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Wolfe Tory Medical, Inc. · Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
55 daysmedian FDA review time
163 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K021044 | MADETT | Wolfe Tory Medical, Inc. | 2002-09-11 | 163 | 8 |
| K002255 | LARYNGO-TRACHEAL MUCOSAL ATOMIZATION DEVICE (MADGIC) | Wolfe Tory Medical, Inc. | 2000-09-18 | 55 | 0 |
| K990556 | ESOPHAGEAL INTUBATION DETECTOR | Wolfe Tory Medical, Inc. | 1999-03-26 | 32 | 0 |
| K945745 | ESOPHAGEAL INTUBATION DETECTOR ADAPTER - (EID-ADAPTER) | Wolfe Tory Medical, Inc. | 1994-12-07 | 14 | 0 |
| K942628 | ESOPHAGEAL INTUBATION DETECTOR BULB | Wolfe Tory Medical, Inc. | 1994-08-18 | 77 | 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