Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Micro-Ear Technology, Inc. — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
83 daysmedian FDA review time
125 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K041302 | REFUGE SOUND GENERATOR | Micro-Ear Technology, Inc. | 2004-07-01 | 48 | 0 |
| K972431 | MERIDIAN DSP | Micro-Ear Technology, Inc. | 1997-07-23 | 29 | 0 |
| K970880 | POWER D, TRU 5, PERSONA, PERSONA CHOICE, MERIDIAN | Micro-Ear Technology, Inc. | 1997-06-06 | 88 | 0 |
| K964657 | SUPER K-AMP, EZ-COMPRESSION, TRIM-PRO, HF-PRO, ENVIRO-PRO, C | Micro-Ear Technology, Inc. | 1997-02-11 | 83 | 0 |
| K934149 | MICRO-TECH TRU CANAL | Micro-Ear Technology, Inc. | 1993-12-27 | 125 | 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