Organon Teknika Corp.: FDA filings under this applicant name
FDA lists 130 510(k) clearances under the applicant name “Organon Teknika Corp.” (first 1980, latest 2000), plus 4 PMA decisions, across 60 product codes in 8 review panels. Median 510(k) review time under this name: 66 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 |
|---|---|---|---|
| MDB | System, Blood Culturing | 19 | 19 |
| FKT | System, Dialysate Delivery, Sorbent Regenerated | 9 | 9 |
| JTN | Susceptibility Test Discs, Antimicrobial | 8 | 8 |
| FJI | Dialyzer, Capillary, Hollow Fiber | 7 | 7 |
| DAP | Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control | 5 | 5 |
| GJS | Test, Time, Prothrombin | 5 | 5 |
| JPA | System, Multipurpose For In Vitro Coagulation Studies | 5 | 5 |
| KOC | Accessories, Blood Circuit, Hemodialysis | 5 | 5 |
| LIB | Device, General Purpose, Microbiology, Diagnostic | 4 | 4 |
| GKP | Instrument, Coagulation, Automated | 3 | 3 |
Plus 50 more product codes.
Review panels
- Microbiology (45)
- Gastroenterology and Urology (32)
- Hematology (31)
- Clinical Chemistry (16)
- Immunology (4)
- Anesthesiology (3)
- General Hospital (1)
- Radiology (1)
Most recent Organon Teknika Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K003104 | BACT/ALERT CSR | LJF | 2000-10-20 | 52 |
| K000492 | MDA D-DIMER | DAP | 2000-06-07 | 113 |
| K000378 | BACT/ALERT MB CULTURE BOTTLE | MDB | 2000-03-02 | 24 |
| K994343 | BACT/ALERT SV | MDB | 2000-02-10 | 49 |
| K993423 | BACT/ALERT SA | MDB | 1999-12-15 | 64 |
| K993576 | BACT/ALERT MP PROCESS BOTTLE | MDB | 1999-12-14 | 54 |
| K993421 | BACT/ALERT SN | MDB | 1999-12-14 | 63 |
| K992432 | BACT/ALERT FN | MDB | 1999-09-24 | 65 |
| K983762 | NUCLISENS CMV PP67 | LIN | 1999-09-15 | 324 |
| K992401 | BACT/ALERT PF | MDB | 1999-09-03 | 46 |
120 earlier clearances. See the full list in Caduvo.
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| P830018 | PMA | HEPANOSTIKA(TM) ANTI-HAV MIDROELISA SYSTEM | 1989-02-06 |
| P840070 | PMA | HEPANOSTIKA(TM) HBEAG/ANTI HBE MICROELISA(TM) SYST | 1986-05-14 |
| P830010 | PMA | CURESIS PLASMA SEPARATOR | 1984-09-19 |
| N50524 | PMA | AUTOBAC MIC TEST SYSTEM | 1979-05-04 |
Recalls
1 product recalls in 1 recall events; 0 initiated in the last five years. Most recent: 2019-01-11.
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.
- Organon, Inc. (42 510(k)s)
- Organon Teknika Treyburn (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Organon Teknika Corp.?
FDA lists 130 510(k) clearances under the applicant name “Organon Teknika Corp.” (first 1980, latest 2000), plus 4 PMA decisions, across 60 product codes in 8 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 Organon Teknika Corp.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Organon Teknika Corp. is 66 days.
Which FDA product codes appear under Organon Teknika Corp.?
The most frequent FDA product codes under this applicant name are MDB (System, Blood Culturing, 19); FKT (System, Dialysate Delivery, Sorbent Regenerated, 9); JTN (Susceptibility Test Discs, Antimicrobial, 8).
Next steps
- See all 130 Organon Teknika Corp. clearances with predicates and recalls
- Run predicate analysis for product code MDB, Organon Teknika 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.