Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Active Electronics, Inc. — Predicate Candidate Screening
7 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
8 daysmedian FDA review time
56 days90th percentile
7clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K945218 | ACTIVE MODEL CIC | Active Electronics, Inc. | 1994-12-21 | 56 | 0 |
| K910704 | ACTIVE MODEL AMC MINI CANAL ITE HEARING AID | Active Electronics, Inc. | 1991-02-28 | 8 | 0 |
| K910705 | ACTIVE MODEL AHX HELIX ITE HEARING AID | Active Electronics, Inc. | 1991-02-28 | 8 | 0 |
| K910701 | ACTIVE MODEL ALP LOW PROFILE ITE HEARING AID | Active Electronics, Inc. | 1991-02-28 | 8 | 0 |
| K910702 | ACTIVE MODEL AHS HALF SHELL ITE HEARING AID | Active Electronics, Inc. | 1991-02-28 | 8 | 0 |
| K910700 | ACTIVE MODEL AST CUSTOM ITE HEARING AID | Active Electronics, Inc. | 1991-02-28 | 8 | 0 |
| K910703 | ACTIVE MODEL ACA CUSTOM CANAL ITE HEARING AID | Active Electronics, Inc. | 1991-02-28 | 8 | 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