Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Micro Audiometrics Corp. — Predicate Candidate Screening
6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
85 daysmedian FDA review time
369 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K982878 | EARSCAN 3 | Micro Audiometrics Corp. | 1998-11-03 | 81 | 0 |
| K924543 | DSP SCREENING AUDIOMETER | Micro Audiometrics Corp. | 1993-02-26 | 171 | 0 |
| K913589 | EARSCAN DSP-1 PURE TONE AUDIOMETER | Micro Audiometrics Corp. | 1991-11-05 | 85 | 0 |
| K904270 | BIOLINK AUDIOMETER SOFTWARE ACCESSORY | Micro Audiometrics Corp. | 1990-10-09 | 21 | 0 |
| K883505 | BIOMETER AUDIOMETER | Micro Audiometrics Corp. | 1989-08-21 | 369 | 0 |
| K812529 | EARSCAN | Micro Audiometrics Corp. | 1981-10-14 | 42 | 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