Synectics Medical, Inc.: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Synectics Medical, Inc.” (first 1994, latest 1997), across 5 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 |
|---|---|---|---|
| BZG | Spirometer, Diagnostic | 1 | 1 |
| EXY | Uroflowmeter | 1 | 1 |
| FAP | Cystometric Gas (Carbon-Dioxide) On Hydraulic Device | 1 | 1 |
| KLA | Monitor, Esophageal Motility, Anorectal Motility, And Tube | 1 | 1 |
| MMZ | Table, Cystometric, Electric | 1 | 1 |
Review panels
Most recent Synectics Medical, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K963330 | URODYNAMIC ANALYSIS MODULE | FAP | 1997-04-03 | 223 |
| K961070 | ESOPHAGEAL MANOMETRY ANALYSIS MODULE | KLA | 1996-06-11 | 85 |
| K951442 | FLOLAB | EXY | 1995-08-24 | 148 |
| K946322 | POLYGRAM SOFTWARE | BZG | 1995-07-07 | 191 |
| K942445 | SYNERGY II | MMZ | 1994-11-22 | 183 |
Recalls
openFDA lists no recalls under a recalling firm named Synectics Medical, Inc..
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.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Synectics AB (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Synectics Medical, Inc.?
FDA lists 5 510(k) clearances under the applicant name “Synectics Medical, Inc.” (first 1994, latest 1997), across 5 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 Medical, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Synectics Medical, Inc. is 183 days.
Which FDA product codes appear under Synectics Medical, Inc.?
The most frequent FDA product codes under this applicant name are BZG (Spirometer, Diagnostic, 1); EXY (Uroflowmeter, 1); FAP (Cystometric Gas (Carbon-Dioxide) On Hydraulic Device, 1).
Next steps
- See all 5 Synectics Medical, Inc. clearances with predicates and recalls
- Run predicate analysis for product code BZG, Synectics Medical, Inc.'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.