Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Medi-Source, 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) |
|---|---|---|---|---|---|
| K903402 | GEOHESIVE (TM), MODEL NUMBERS 1022L, 1023L, 1026L | Medi-Source, Inc. | 1990-08-22 | 22 | 0 |
| K890565 | GELLHORN PESSARY 33410 VARIOUS SIZES | Medi-Source, Inc. | 1989-03-29 | 51 | 0 |
| K890566 | BERMAN TYPE AIRWAY #59422-59429 VARIOUS SIZES | Medi-Source, Inc. | 1989-03-15 | 37 | 0 |
| K890567 | BITE BLOCK #59430 | Medi-Source, Inc. | 1989-02-17 | 11 | 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