Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Alphamed, 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) |
|---|---|---|---|---|---|
| K190210 | Tear Pool Dissolvable Punctum Plugs | Alphamed, Inc. | 2019-10-24 | 262 | 0 |
| K091240 | ALPHAMED SURGICAL SPEAR, MODEL 70-5000 | Alphamed, Inc. | 2009-10-23 | 179 | 0 |
| K990321 | ALPHAMED GEMINI SENSOR, SNORING SENSOR | Alphamed, Inc. | 1999-06-01 | 120 | 0 |
| K926446 | EZ PUMP | Alphamed, Inc. | 1993-09-27 | 278 | 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