Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Amco International Manufacturing & Design, Inc. · Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
102 daysmedian FDA review time
225 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K091548 | AMCO REPLACEMENT BATTERY FOR PHILIPS MEDICAL MODELS BT1 AND | Amco International Manufacturing & Design, Inc. | 2009-08-07 | 72 | 0 |
| K082861 | AMCO REPLACEMENT BATTERY FOR POWERHEART AED, NON-RECHARGEABL | Amco International Manufacturing & Design, Inc. | 2008-11-25 | 57 | 0 |
| K073716 | LIFE+CEL OR LIFECEL BATTERY | Amco International Manufacturing & Design, Inc. | 2008-04-11 | 102 | 0 |
| K072596 | LIFE+CEL OR LIFECEL BATTERY PACK, MODEL 5L500 | Amco International Manufacturing & Design, Inc. | 2008-01-24 | 132 | 0 |
| K071164 | LIFE+CEL BATTERY | Amco International Manufacturing & Design, Inc. | 2007-12-07 | 225 | 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