Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
ESE — Predicate Candidate Screening
13 FDA 510(k) clearances under this product code; the 50 most recent screened below.
85 daysmedian FDA review time
260 days90th percentile
13clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K934483 | NU-VOIS BATTERY POWERED ARTIFICIAL LARYNX | Mountain Precision Mfg. Ltd. Co. | 1994-03-16 | 183 | 0 |
| K931371 | DENRICK SPEECH AID (DR-1) | Denrick Corp. | 1993-08-25 | 161 | 0 |
| K923648 | LECTRO-LARYNX | Bruce Medical Supply | 1993-04-07 | 260 | 0 |
| K914816 | AMERICAN ARTIFICIAL LARYNX | Ultravoice, Ltd. | 1993-02-12 | 476 | 0 |
| K901503 | ADDVOX BONE CONDUCTOR AMPLIFIER SPEAKER SYSTEM | Stanton Magnetics, Inc. | 1990-06-28 | 90 | 0 |
| K860992 | VOX COMPANION | Bloomfield Research and Development, Inc. | 1986-05-02 | 46 | 0 |
| K860993 | P.O. VOX | Bloomfield Research and Development, Inc. | 1986-04-25 | 39 | 0 |
| K854158 | RESNICK EMITTER, ARTIFICIAL LARYNX | Dynamed Audio, Inc. | 1985-12-13 | 63 | 0 |
| K840892 | ELECTRO-PALATE | Cisko Systems | 1984-05-22 | 85 | 0 |
| K834555 | BEAR VENTI--VOICE | Bear Medical Systems, Inc. | 1984-01-24 | 28 | 0 |
| K834522 | VENTI-VOICE NASAL CATHETER | Respiratory Support Products, Inc. | 1984-01-17 | 27 | 0 |
| K831127 | INTRA-ORAL ARTIFICIAL LARYNX | Xomed, Inc. | 1983-07-28 | 113 | 0 |
| K823118 | SAY | Kells Medical, Inc. | 1983-01-07 | 78 | 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