Organon, Inc.: FDA filings under this applicant name
FDA lists 42 510(k) clearances under the applicant name “Organon, Inc.” (first 1977, latest 2026), across 21 product codes in 6 review panels. Median 510(k) review time under this name: 30 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 | 1 | 177 |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Organon, Inc. took a median 177 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 120 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| JHJ | Agglutination Method, Human Chorionic Gonadotropin | 11 | 11 |
| JHI | Visual, Pregnancy Hcg, Prescription Use | 4 | 4 |
| DHR | System, Test, Rheumatoid Factor | 2 | 2 |
| GIM | Tubes, Vacuum Sample, With Anticoagulant | 2 | 2 |
| GOK | Antisera, Hai (Including Hai Control), Rubella | 2 | 2 |
| KTN | System, Test, Infectious Mononucleosis | 2 | 2 |
| KXT | Enzyme Immunoassay, Digoxin | 2 | 2 |
| LCX | Kit, Test, Pregnancy, Hcg, Over The Counter | 2 | 2 |
| CDX | Radioimmunoassay, Total Thyroxine | 1 | 1 |
| DEW | Igg, Antigen, Antiserum, Control | 1 | 1 |
Plus 11 more product codes.
Review panels
- Clinical Chemistry (25)
- Microbiology (5)
- General Hospital (3)
- Immunology (3)
- Clinical Toxicology (2)
- Obstetrics and Gynecology (1)
Most recent Organon, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K253642 | Jada System (Jada-2002) | OQY | 2026-05-15 | 177 |
| K950861 | RECONSTITUTION ACCESSOREIS | FPK | 1995-05-26 | 88 |
| K853388 | MONOSTICON UNI-DOT | KTN | 1985-08-22 | 9 |
| K842314 | DUOCLON COLOR-CEPT | JHJ | 1984-08-24 | 73 |
| K841525 | OREIA II B-HCG PREGNANCY TEST KIT | JHI | 1984-06-05 | 54 |
| K841602 | ACCURATE BETA 30 PREGNANCY TEST KIT | LCX | 1984-05-22 | 34 |
| K840650 | B-NEOCEPT 30 | JHJ | 1984-04-04 | 49 |
| K832801 | OREIA II B-HCG, ENZYME INNUNOASSAY | JHI | 1983-12-08 | 112 |
| K831339 | NEO-PREGNOSTICON DUOCLON TUBE TEST | JHJ | 1983-06-08 | 44 |
| K831109 | DUOCLON SLIDE TEST | JHI | 1983-06-02 | 58 |
32 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Organon, 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.
SEC filings
Organon & Co. (OGN): EDGAR filings, CIK 1821825. An SEC registrant with the same name, matched by name only.
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 Teknika Corp. (130 510(k)s)
- Organon Teknika Treyburn (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Organon, Inc.?
FDA lists 42 510(k) clearances under the applicant name “Organon, Inc.” (first 1977, latest 2026), across 21 product codes in 6 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, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Organon, Inc. is 30 days.
Which FDA product codes appear under Organon, Inc.?
The most frequent FDA product codes under this applicant name are JHJ (Agglutination Method, Human Chorionic Gonadotropin, 11); JHI (Visual, Pregnancy Hcg, Prescription Use, 4); DHR (System, Test, Rheumatoid Factor, 2).
Next steps
- See all 42 Organon, Inc. clearances with predicates and recalls
- Run predicate analysis for product code JHJ, Organon, 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.