Terragene S.A.: FDA filings under this applicant name
FDA lists 7 510(k) clearances under the applicant name “Terragene S.A.” (first 2017, latest 2024), plus 1 De Novo decision, across 4 product codes in 1 review panel. Median 510(k) review time under this name: 266 days. Since 2017 the median was 266 days, against 100 days for all cleared 510(k)s in the same product codes. 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 |
|---|---|---|
| 2017 | 1 | 314 |
| 2018 | 0 | — |
| 2019 | 1 | 149 |
| 2020 | 1 | 147 |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 1 | 267 |
| 2024 | 3 | 266 |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Terragene S.A. took a median 266 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 100 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| FRC | Indicator, Biological Sterilization Process | 5 | 5 |
| JOJ | Indicator, Physical/Chemical Sterilization Process | 1 | 1 |
| QKM | A Chemical Vapor Sterilization Multivariable Chemical Indicator | 1 | 1 |
| QVB | Biological Sterilization Indicator With Indirect Growth Detection | 1 | 0 |
Review panels
- General Hospital (8)
Most recent Terragene S.A. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K242453 | Terragene® Bionova® Photon Process Challenge Device with unique-point integrator (PCD225-2);Terragene® Bionova® Photon Process Challenge Device with moving-front integrator (PCD225-C) | FRC | 2024-12-12 | 115 |
| K231383 | Terragene® Bionova® Self-Contained Biological Indicator (BT95), Terragene® Bionova® Self-Contained Biological Indicator (BT96), Terragene® Chemdye® Chemical Process Indicator (CD42), Terragene® Cintape® Chemical Process Indicator Tape (CT40) | FRC | 2024-09-18 | 495 |
| K232103 | Terragene® Chemdye® Multivariable Chemical Indicator (CD40), Terragene® Chemdye® Chemical Process Indicator (CD42), Terragene® Cintape® Chemical Process Indicator Tape (CT40) | QKM | 2024-04-05 | 266 |
| K221641 | Terragene® Bionova® Hyper Biological Indicator (BT98), Terragene® Bionova® Hyper Auto-reader Incubator (BHY), Terragene® Bionova® NanoBio Auto-reader Incubator (BNB) | FRC | 2023-02-28 | 267 |
| K200272 | Terragene Chemdye | JOJ | 2020-06-30 | 147 |
| K191021 | Terragene Bionova, Terragene Bionova, Terragene Integron, Terragene Cintape, Terragene Chemdye | FRC | 2019-09-13 | 149 |
| K163646 | Terragene Bionova(R) SCBI (BT220, BT221, BT222, BT223), Terragene Bionova (R) PCD (PCD220-C, PCD220-2, PCD222-C, PCD222-2), and Terragene Bionova(R) IC10/20FR Reader Incubator | FRC | 2017-11-02 | 314 |
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| DEN220042 | De Novo | Biological Sterilization Indicator With Indirect Growth Detection | 2024-07-12 |
Recalls
3 product recalls in 2 recall events; 3 initiated in the last five years. Most recent: 2025-01-15.
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.
- Terragene (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Terragene S.A.?
FDA lists 7 510(k) clearances under the applicant name “Terragene S.A.” (first 2017, latest 2024), plus 1 De Novo decision, across 4 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Terragene S.A.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Terragene S.A. is 266 days. Since 2017: 266 days, versus 100 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Terragene S.A.?
The most frequent FDA product codes under this applicant name are FRC (Indicator, Biological Sterilization Process, 5); JOJ (Indicator, Physical/Chemical Sterilization Process, 1); QKM (A Chemical Vapor Sterilization Multivariable Chemical Indicator, 1).
Next steps
- See all 7 Terragene S.A. clearances with predicates and recalls
- Run predicate analysis for product code FRC, Terragene S.A.'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 (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.