Ortho-Clinical Diagnostics, Inc.: FDA clearances and approvals
Ortho-Clinical Diagnostics, Inc. has 126 FDA 510(k) clearances (first 1997, latest 2025), plus 7 PMA and 2 De Novo decisions, across 77 product codes in 5 review panels. Median 510(k) review time: 53 days. Since 2017 its median was 30 days, against 180 days for all cleared 510(k)s in the same product codes. openFDA lists 316 product recalls by a recalling firm named Ortho-Clinical Diagnostics, Inc.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 2 | 208 |
| 2013 | 3 | 146 |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 2 | 134 |
| 2017 | 0 | — |
| 2018 | 2 | 90 |
| 2019 | 5 | 28 |
| 2020 | 0 | — |
| 2021 | 1 | 143 |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 1 | 90 |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, Ortho-Clinical Diagnostics, Inc.'s cleared 510(k)s took a median 30 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 180 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) | 13 | 13 |
| MMI | Immunoassay Method, Troponin Subunit | 6 | 6 |
| JFY | Enzymatic Method, Creatinine | 5 | 5 |
| JJY | Multi-Analyte Controls, All Kinds (Assayed) | 5 | 5 |
| JIX | Calibrator, Multi-Analyte Mixture | 4 | 4 |
| SEI | Qualitative And Quantitative Hepatitis B Virus Antibody Assays | 4 | 0 |
| JIS | Calibrator, Primary | 3 | 3 |
| JIT | Calibrator, Secondary | 3 | 3 |
| KHS | Enzymatic, Carbon-Dioxide | 3 | 3 |
| CDD | Radioassay, Vitamin B12 | 2 | 2 |
Plus 67 more product codes.
Review panels
- Clinical Chemistry (85)
- Immunology (17)
- Clinical Toxicology (16)
- Microbiology (15)
- Hematology (2)
Most recent Ortho-Clinical Diagnostics, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K252393 | VITROS Immunodiagnostic Products hs Troponin I Reagent Pack | MMI | 2025-10-29 | 90 |
| K210858 | VITROS Chemistry Products PHBR Slides | DLZ | 2021-08-13 | 143 |
| K191316 | VITROS XT Chemistry Products ALB-TP Slides | CIX | 2019-06-07 | 23 |
| K190807 | VITROS XT Chemistry Products TBIL-ALKP Slides | CIG | 2019-04-26 | 28 |
| K190520 | VITROS XT Chemistry Products GLU-Ca Slides | CGA | 2019-04-03 | 30 |
| K190490 | VITROS XT Chemistry Products TRIG-CHOL Slides | CHH | 2019-03-27 | 27 |
| K190326 | VITROS XT Chemistry Products UREA-CREA Slides | CDN | 2019-03-14 | 29 |
| K182072 | VITROS Chemistry Products Cl-Slides, VITROS Chemistry Products ECO2 Slides, VITROS Chemistry Products GLU Slides | CGZ | 2018-10-30 | 90 |
| K182063 | VITROS Chemistry Products CRBM Slides, VITROS Chemistry Products CREA Slides, VITROS Chemistry Products TBIL Slides, VITROS XT 7600 Integrated System | JFY | 2018-10-30 | 90 |
| K160495 | VITROS® Automation Solutions | KLI | 2016-10-18 | 239 |
116 earlier clearances. See the full list in Caduvo.
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| DEN210040 | De Novo | Sars-Cov-2 Serology Test | 2023-05-05 |
| DEN210038 | De Novo | Sars-Cov-2 Serology Test | 2023-05-05 |
| P100001 | PMA | VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBE REAGENT PACK/ANTI-HBE CALIBRATOR/ANTI HBE CONTROLS | 2011-07-20 |
| P090028 | PMA | VITROS IMMUNODIAGNOSTIC PRODUCTS HBEAG REAGENT PACK/PRODUCTS HBEAG CALIBRATOR/PRODUCTS HBE CONTROLS | 2011-05-11 |
| P030026 | PMA | VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC IGM REAGENT PAK/CALIBRATOR | 2004-03-04 |
Recalls
316 product recalls in 180 recall events; 71 initiated in the last five years. Most recent: 2025-07-29.
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Ortho-Clinical Diagnostics, Inc. have?
Ortho-Clinical Diagnostics, Inc. has 126 FDA 510(k) clearances (first 1997, latest 2025), plus 7 PMA and 2 De Novo decisions, across 77 product codes in 5 review panels.
How long does FDA take to clear Ortho-Clinical Diagnostics, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Ortho-Clinical Diagnostics, Inc.'s cleared 510(k)s is 53 days. Since 2017: 30 days, versus 180 days for all cleared 510(k)s in the same product codes.
What devices does Ortho-Clinical Diagnostics, Inc. make?
Its most frequent FDA product codes are JJX (Single (Specified) Analyte Controls (Assayed And Unassayed), 13); MMI (Immunoassay Method, Troponin Subunit, 6); JFY (Enzymatic Method, Creatinine, 5).
Has Ortho-Clinical Diagnostics, Inc. had device recalls?
openFDA lists 316 product recalls in 180 recall events by a recalling firm whose name matches Ortho-Clinical Diagnostics, Inc; the most recent began 2025-07-29. Recall firm names are matched by name, so related entities filing under other names are not included.
Next steps
- See all 126 Ortho-Clinical Diagnostics, Inc. clearances with predicates and recalls
- Run predicate analysis for product code JJX, Ortho-Clinical Diagnostics, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.