Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Amplife Corporation — 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) |
|---|---|---|---|---|---|
| K050413 | AMPLIEF WRIST BLOOD PRESSURE MONITOR, MODEL M600 | Amplife Corporation | 2005-03-04 | 14 | 0 |
| K043550 | AMPLIFE UPPER ARM BLOOD PRESSURE MONITOR, MODEL M100 | Amplife Corporation | 2005-01-27 | 35 | 0 |
| K042906 | AMPLIFE DIGITAL INFRARED EAR THERMOMETER, MODEL E101 | Amplife Corporation | 2004-11-19 | 29 | 0 |
| K042575 | AMPLIFE DIGITAL CLINICAL THERMOMETER | Amplife Corporation | 2004-09-30 | 8 | 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