Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Mini-Mitter Co., Inc. — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
164 daysmedian FDA review time
176 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K033534 | VITALSENSE | Mini-Mitter Co., Inc. | 2004-04-22 | 164 | 0 |
| K011430 | ACTIWARE-PLMS | Mini-Mitter Co., Inc. | 2001-05-31 | 22 | 0 |
| K991045 | MINI-LOGGER SERIES 2000 | Mini-Mitter Co., Inc. | 1999-09-21 | 176 | 0 |
| K991033 | ACTIWATCH-SCORE | Mini-Mitter Co., Inc. | 1999-06-23 | 86 | 0 |
| K983533 | ACTIWATCH | Mini-Mitter Co., Inc. | 1999-03-23 | 166 | 3 |
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