Synectics-Dantec: FDA filings under this applicant name
FDA lists 19 510(k) clearances under the applicant name “Synectics-Dantec” (first 1985, latest 1997), across 6 product codes in 2 review panels. Median 510(k) review time under this name: 183 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| FFT | Electrode, Ph, Stomach | 10 | 10 |
| BZG | Spirometer, Diagnostic | 2 | 2 |
| BZQ | Monitor, Breathing Frequency | 2 | 2 |
| FAP | Cystometric Gas (Carbon-Dioxide) On Hydraulic Device | 2 | 2 |
| KLA | Monitor, Esophageal Motility, Anorectal Motility, And Tube | 2 | 2 |
| FFX | System, Gastrointestinal Motility (Electrical) | 1 | 1 |
Review panels
Most recent Synectics-Dantec 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K961346 | PH ANALYSIS MODULE | FFT | 1997-01-29 | 320 |
| K925405 | ZINETICS COMPOSITE SENSOR PROBE W/INTERNAL REF. | FFT | 1994-09-30 | 704 |
| K924875 | MICROTRAPPER/MICRODIGITRAPPER, ADD MODIFICATIONS | BZQ | 1994-06-30 | 654 |
| K914793 | MONOCRYSTANT PH/LES CATHETER, MODIFICATION | KLA | 1993-12-13 | 840 |
| K924383 | SYNECTICS LIBERTY SYSTEM, PC POLYGRAF/POLYGRAM URO | FAP | 1993-06-18 | 297 |
| K913817 | MONOCRYSTANT PH-REFERENCE CATHETER, MODIFICATION | FFT | 1992-06-11 | 290 |
| K914624 | PH METER, MODIFICATION | FFT | 1992-04-28 | 195 |
| K914219 | AIRWAY THERMISTOR | BZG | 1992-02-26 | 160 |
| K913387 | DIGITRAPPER MARK III | FFT | 1991-12-27 | 151 |
| K904625 | SYNECTICS LIBERTY SYSTEM, PC POLYGRAF AND POLYGRAM | BZG | 1991-08-20 | 314 |
9 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Synectics-Dantec.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Frequently asked questions
How many FDA 510(k) clearances are listed under Synectics-Dantec?
FDA lists 19 510(k) clearances under the applicant name “Synectics-Dantec” (first 1985, latest 1997), across 6 product codes in 2 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Synectics-Dantec?
The median time from FDA receipt to decision across 510(k)s cleared under the name Synectics-Dantec is 183 days.
Which FDA product codes appear under Synectics-Dantec?
The most frequent FDA product codes under this applicant name are FFT (Electrode, Ph, Stomach, 10); BZG (Spirometer, Diagnostic, 2); BZQ (Monitor, Breathing Frequency, 2).
Next steps
- See all 19 Synectics-Dantec clearances with predicates and recalls
- Run predicate analysis for product code FFT, Synectics-Dantec's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.