Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Micro Tronics Corp. — Predicate Candidate Screening
6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
96 daysmedian FDA review time
294 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K901797 | THE WONDER BOX | Micro Tronics Corp. | 1991-02-07 | 294 | 0 |
| K890513 | SAC 747 AND SAC 847 (SLEEP ANALYZING COMPUTERS) | Micro Tronics Corp. | 1989-04-28 | 86 | 0 |
| K863124 | MODEL 8 EEG PREAMPLIFIER | Micro Tronics Corp. | 1986-11-18 | 96 | 0 |
| K862527 | SLEEP ANALYZING COMPUTER | Micro Tronics Corp. | 1986-10-06 | 96 | 0 |
| K780838 | PERCI | Micro Tronics Corp. | 1978-07-17 | 56 | 0 |
| K772005 | MYOTONE EMG MONITOR | Micro Tronics Corp. | 1977-11-23 | 33 | 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