Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Dantec Medical, Inc. — Predicate Candidate Screening
25 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
211 daysmedian FDA review time
736 days90th percentile
25clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K960503 | DANTEC DUET | Dantec Medical, Inc. | 1996-09-16 | 227 | 0 |
| K950314 | DANTEC MONOPOLAR LUMEN ELECTRODE (13R18 AND 13R19) | Dantec Medical, Inc. | 1996-03-25 | 424 | 0 |
| K953999 | DANTEC DA CAPO | Dantec Medical, Inc. | 1995-11-21 | 89 | 0 |
| K926363 | MULTI-DOP S | Dantec Medical, Inc. | 1995-06-19 | 910 | 0 |
| K931801 | MULTI-DOP X | Dantec Medical, Inc. | 1995-06-14 | 867 | 0 |
| K930458 | MULTI-DOP L | Dantec Medical, Inc. | 1995-02-03 | 736 | 0 |
| K932059 | NEEDLE ELECTRODES AND DISPOSABLE SCALP ELECTRODE | Dantec Medical, Inc. | 1994-10-04 | 523 | 0 |
| K934580 | DANTEC 13R45 BAR ELECTRODE | Dantec Medical, Inc. | 1994-09-26 | 368 | 0 |
| K931966 | DANTEC DISPOSABLE CONCENTRIC NEEDLE | Dantec Medical, Inc. | 1994-03-30 | 343 | 0 |
| K931923 | DANTEC MAGLITE MAGNETIC STIMULATOR (MAGLITE) | Dantec Medical, Inc. | 1993-11-09 | 207 | 0 |
| K926516 | DANTEC MAGNETIC STIMULATOR MAGPRO | Dantec Medical, Inc. | 1993-08-31 | 244 | 0 |
| K924127 | DANTEC EVOLUTION | Dantec Medical, Inc. | 1993-03-10 | 205 | 0 |
| K923117 | CAVERNOSOMETRY MODULE FOR MENUET | Dantec Medical, Inc. | 1993-02-22 | 241 | 0 |
| K915741 | DISPOSABLE MONOPLAR MEDDLE ELECTRODES | Dantec Medical, Inc. | 1992-12-08 | 354 | 0 |
| K913957 | DANTEC COUNTERPOINT MK2(TM) | Dantec Medical, Inc. | 1992-01-30 | 148 | 0 |
| K913169 | DANTEC UD 5500 MK2 | Dantec Medical, Inc. | 1992-01-23 | 190 | 0 |
| K914891 | PULLER OPTION FOR ETUDE(TM) | Dantec Medical, Inc. | 1992-01-07 | 68 | 0 |
| K912701 | DANTEC MENUET | Dantec Medical, Inc. | 1991-12-09 | 173 | 0 |
| K911229 | PHOENIX DIGITAL EEG SYSTEM | Dantec Medical, Inc. | 1991-09-30 | 194 | 0 |
| K913323 | ETUDE (MODEL NUMBERS 24A05 & 24A06) | Dantec Medical, Inc. | 1991-09-23 | 60 | 0 |
| K902607 | DANTEC MAGNETIC STIMULATOR MAG 2 (MAG 2) | Dantec Medical, Inc. | 1991-05-14 | 336 | 0 |
| K901494 | ETUDE, URODYNAMIC INVESTIGATION SYSTEM | Dantec Medical, Inc. | 1990-10-26 | 211 | 0 |
| K896874 | DANTEC ELECTRODES MODEL DNE 116, 117 & 13P02/12 | Dantec Medical, Inc. | 1990-06-18 | 192 | 0 |
| K896575 | DANTEC MENUET | Dantec Medical, Inc. | 1990-05-03 | 164 | 0 |
| K896567 | CANTATA EMG/EVOKED RESPONSE SYSTEM | Dantec Medical, Inc. | 1990-02-16 | 88 | 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