Syntex Corp.: FDA filings under this applicant name
FDA lists 10 510(k) clearances under the applicant name “Syntex Corp.” (first 1976, latest 1992), across 7 product codes in 4 review panels. Median 510(k) review time under this name: 18 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 |
|---|---|---|---|
| JAK | System, X-Ray, Tomography, Computed | 4 | 4 |
| DIS | Enzyme Immunoassay, Barbiturate | 1 | 1 |
| DYN | Mouthpiece, Saliva Ejector | 1 | 1 |
| EAY | Light, Fiber Optic, Dental | 1 | 1 |
| EFB | Handpiece, Air-Powered, Dental | 1 | 1 |
| EJJ | Alloy, Amalgam | 1 | 1 |
| HRQ | Hemostat | 1 | 1 |
Review panels
- Dental (4)
- Radiology (4)
- General and Plastic Surgery (1)
- Clinical Toxicology (1)
Most recent Syntex Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K920314 | TXIT D.A.U. BARBITURATE ASSAY (MODIFICATION) | DIS | 1992-04-17 | 85 |
| K843593 | SURGIPRESS SURGICAL LOOP | HRQ | 1984-10-24 | 42 |
| K780997 | AMALGAM ALLOY | EJJ | 1978-07-27 | 43 |
| K780769 | S-100 CT SCANNER | JAK | 1978-06-02 | 28 |
| K780483 | FIBER OPTIC HANDPIECE | EFB | 1978-04-28 | 32 |
| K761331 | OPUS I OPTION - FIBER OPTIC L SYSTEM | EAY | 1977-01-03 | 7 |
| K761332 | HI-SENSITIVITY MODE OPTION FOR S60-1A | JAK | 1976-12-30 | 3 |
| K761330 | SYNTEX SYSTEM 6000 | JAK | 1976-12-30 | 3 |
| K761264 | OPTIONS FOR STAR DENTAL OPUS I | DYN | 1976-12-23 | 7 |
| K761033 | COMPUTERIZED TOMOGRAPHY SCANNER | JAK | 1976-11-24 | 9 |
Recalls
openFDA lists no recalls under a recalling firm named Syntex Corp..
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.
- Syntex Healthcare Products Co., Ltd. (17 510(k)s)
- Syntex Dental Products, Inc. (3 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Syntex Corp.?
FDA lists 10 510(k) clearances under the applicant name “Syntex Corp.” (first 1976, latest 1992), across 7 product codes in 4 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 Syntex Corp.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Syntex Corp. is 18 days.
Which FDA product codes appear under Syntex Corp.?
The most frequent FDA product codes under this applicant name are JAK (System, X-Ray, Tomography, Computed, 4); DIS (Enzyme Immunoassay, Barbiturate, 1); DYN (Mouthpiece, Saliva Ejector, 1).
Next steps
- See all 10 Syntex Corp. clearances with predicates and recalls
- Run predicate analysis for product code JAK, Syntex Corp.'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.