Predicate Research Report · generated 2026-08-21 · Print / save as PDF · Save to account
Synectics-Dantec — Predicate Candidate Screening
19 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
183 daysmedian FDA review time
704 days90th percentile
19clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K961346 | PH ANALYSIS MODULE | Synectics-Dantec | 1997-01-29 | 320 | 0 |
| K925405 | ZINETICS COMPOSITE SENSOR PROBE W/INTERNAL REF. | Synectics-Dantec | 1994-09-30 | 704 | 0 |
| K924875 | MICROTRAPPER/MICRODIGITRAPPER, ADD MODIFICATIONS | Synectics-Dantec | 1994-06-30 | 654 | 0 |
| K914793 | MONOCRYSTANT PH/LES CATHETER, MODIFICATION | Synectics-Dantec | 1993-12-13 | 840 | 0 |
| K924383 | SYNECTICS LIBERTY SYSTEM, PC POLYGRAF/POLYGRAM URO | Synectics-Dantec | 1993-06-18 | 297 | 0 |
| K913817 | MONOCRYSTANT PH-REFERENCE CATHETER, MODIFICATION | Synectics-Dantec | 1992-06-11 | 290 | 0 |
| K914624 | PH METER, MODIFICATION | Synectics-Dantec | 1992-04-28 | 195 | 0 |
| K914219 | AIRWAY THERMISTOR | Synectics-Dantec | 1992-02-26 | 160 | 0 |
| K913387 | DIGITRAPPER MARK III | Synectics-Dantec | 1991-12-27 | 151 | 0 |
| K904625 | SYNECTICS LIBERTY SYSTEM, PC POLYGRAF AND POLYGRAM | Synectics-Dantec | 1991-08-20 | 314 | 0 |
| K905520 | MICROTRAPPER/MICRODIGITRAPPER, MODIFICATION | Synectics-Dantec | 1991-04-26 | 140 | 0 |
| K900494 | SYNECTICS LIBERTY SYSTEM, PC POLYGRAF & POLYGRAM | Synectics-Dantec | 1990-06-11 | 129 | 0 |
| K902366 | MODIFIED PROXIMA MONITOR/DIGITRAPPER ED UNIT | Synectics-Dantec | 1990-06-08 | 23 | 0 |
| K880581 | AMBUL. PH & MOTILITY RECORDER FOR MEASURE OF PARA. | Synectics-Dantec | 1988-08-11 | 183 | 0 |
| K872712 | PC POLYGRAF | Synectics-Dantec | 1988-03-18 | 252 | 0 |
| K871282 | SYNECTICS LIBERTY SYSTEM AMPLIFIER AND SOFTWARE | Synectics-Dantec | 1987-06-10 | 71 | 0 |
| K862929 | SYNECTICS MOTILITY SYSTEM | Synectics-Dantec | 1986-10-20 | 89 | 0 |
| K853648 | SYNECTICS LIBERTY SYS COMPRIS DIGITRAPPER MK II MO | Synectics-Dantec | 1985-11-18 | 76 | 0 |
| K850361 | SYNECTICS PH SYS COMPRISING DIGITRAPPER MARK II, E | Synectics-Dantec | 1985-05-01 | 91 | 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