Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
LRA — Predicate Candidate Screening
8 FDA 510(k) clearances under this product code; the 50 most recent screened below.
71 daysmedian FDA review time
107 days90th percentile
8clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K883853 | ETA | Sevrain-Tech, Inc. | 1988-11-17 | 65 | 0 |
| K862471 | WEARABLE TWENTY-FOUR CHANNEL VIBROTACTILE VOCODER | Institute of Logopedics | 1986-09-12 | 74 | 0 |
| K851441 | TACTICON 1600 | Medecon | 1985-06-27 | 78 | 0 |
| K851655 | TEACHER TM | Monargue Intl. | 1985-06-20 | 59 | 0 |
| K843433 | KANIEVSKI SENSORY AID OR DEVICE | Spectro Industries, Inc. | 1984-11-14 | 71 | 0 |
| K831501 | TACTIL EAR | Ear Three Systems | 1983-08-26 | 107 | 0 |
| K830418 | TACTAID | Audiological Engineering Corp. | 1983-03-10 | 30 | 0 |
| K813057 | VIBRO-COM COMMUNICATOR #8827 | Sonic Systems, Inc. | 1981-12-02 | 34 | 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