Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
American Imex · Predicate Candidate Screening
11 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
73 daysmedian FDA review time
183 days90th percentile
11clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K032003 | PREMIER PLUS | American Imex | 2004-01-07 | 194 | 0 |
| K982221 | PREMIER AP | American Imex | 1998-09-22 | 90 | 0 |
| K926326 | MICROCARE(TM) | American Imex | 1993-06-01 | 169 | 0 |
| K912289 | ULTIMA XS, MODIFICATION | American Imex | 1991-11-22 | 183 | 0 |
| K895295 | ULTIMA XS MICROCURRENT TENS | American Imex | 1989-11-06 | 73 | 0 |
| K894388 | ZIMMER TENS | American Imex | 1989-08-10 | 24 | 0 |
| K881704 | EASY TENS | American Imex | 1988-05-04 | 15 | 0 |
| K881424 | PREMIER 10S (TENS) | American Imex | 1988-04-11 | 6 | 0 |
| K880751 | ULTIMA XS (TENS) | American Imex | 1988-04-06 | 42 | 0 |
| K864735 | A-TENS - MODEL AI-87 | American Imex | 1987-02-20 | 78 | 0 |
| K861709 | A TENS (MODEL AI-86) | American Imex | 1986-05-16 | 11 | 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