Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Green Field Medical Sourcing, Inc. · Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
294 daysmedian FDA review time
406 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K971759 | MEDPORT EMERGENCY MEDICATION AIRWAY TUBE ADAPTER | Green Field Medical Sourcing, Inc. | 1998-03-02 | 294 | 0 |
| K971348 | FASTTRACH SINGLE-PASS TRACHEAL/ESOPHAGEAL AIRWAY SYSTEM | Green Field Medical Sourcing, Inc. | 1998-02-27 | 323 | 0 |
| K954150 | VENTILATOR, EMERGENCY, MANUAL (RESUSCITATOR) | Green Field Medical Sourcing, Inc. | 1995-12-20 | 106 | 0 |
| K944667 | LIFE PULSE TESUSCITATION TIMER | Green Field Medical Sourcing, Inc. | 1994-10-04 | 14 | 0 |
| K932867 | LIFE PULSE RESUSCITATION TIMER | Green Field Medical Sourcing, Inc. | 1994-07-25 | 406 | 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