Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
A.R. Medicom, Inc. — Predicate Candidate Screening
3 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K070428 | MEDICOM SELF-SEALING STERILIZATION POUCH | A.R. Medicom, Inc. | 2007-07-17 | 154 | 0 |
| K051291 | NON-STERILE SURGICAL MASK | A.R. Medicom, Inc. | 2005-09-20 | 125 | 3 |
| K935257 | MEDICOM NON-WOVEN SPONGES | A.R. Medicom, Inc. | 1994-04-14 | 164 | 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