Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Armm, 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) |
|---|---|---|---|---|---|
| K981286 | SUPERFLOW IRRIGATION AND ASPIRATION TUBING SETS | Armm, Inc. | 1998-06-19 | 72 | 0 |
| K923201 | ENDOSI SUCTION IRRIGATOR | Armm, Inc. | 1993-09-23 | 450 | 0 |
| K922245 | SUPER-FLOW TUBING | Armm, Inc. | 1993-09-03 | 478 | 0 |
| K931607 | MEDDRAINS | Armm, Inc. | 1993-08-06 | 127 | 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