Centers for Disease Control and Prevention: FDA clearances and approvals
Centers for Disease Control and Prevention has 26 FDA 510(k) clearances (first 1981, latest 2026), plus 1 PMA and 4 De Novo decisions, across 13 product codes in 3 review panels. Median 510(k) review time: 36 days. Since 2017 its median was 29 days, against 84 days for all cleared 510(k)s in the same product codes. openFDA lists 1 product recall by a recalling firm named Centers for Disease Control and Prevention.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 3 | 42 |
| 2014 | 3 | 22 |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 1 | 29 |
| 2018 | 1 | 136 |
| 2019 | 2 | 36 |
| 2020 | 1 | 25 |
| 2021 | 0 | — |
| 2022 | 3 | 2 |
| 2023 | 0 | — |
| 2024 | 1 | 29 |
| 2025 | 3 | 91 |
| 2026 | 1 | 17 |
Review time against the same product codes
Since 2017, Centers for Disease Control and Prevention's cleared 510(k)s took a median 29 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 84 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| OZE | Influenza A And Influenza B Multiplex Nucleic Acid Assay | 9 | 9 |
| PBK | Non-Variola Orthopoxvirus Real-Time Pcr Primer And Probe Set | 5 | 4 |
| OQW | 2009 H1n1 Influenza Virus (Swine Origin), Nucleic Acid Or Antigen, Detection And Identification | 4 | 4 |
| LHL | Reagents, Antibody, Legionella, Direct & Indirect Fluorescent | 2 | 2 |
| NXD | Nucleic Acid Amplification, Novel Influenza A Virus, A/H5 (Asian Lineage) Rna | 2 | 1 |
| SGA | Biothreat Microbial Agent Nucleic Acid Detection Test | 2 | 2 |
| DHN | Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control | 1 | 1 |
| GMQ | Antigens, Nontreponemal, All | 1 | 1 |
| LTQ | Calibrator For Alpha-Fetoprotein In Mid-Pregnancy Maternal Serum | 1 | 0 |
| NHT | Assay, Nucleic Acid Amplification, Bacillus Anthracis | 1 | 1 |
Plus 3 more product codes.
Review panels
- Microbiology (28)
- Immunology (2)
- Clinical Toxicology (1)
Most recent Centers for Disease Control and Prevention 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K260812 | Francisella tularensis Real-time PCR Assay | SGA | 2026-03-30 | 17 |
| K252072 | Francisella tularensis Real-time PCR assay | SGA | 2025-09-30 | 91 |
| K243274 | CDC Human Influenza Virus Real-Time RT-PCR Diagnostic Panel: Influenza A/B Typing Kit (VER 2); Influenza A SubTyping Kit (VER 4); Influenza B Genotyping Kit (VER 1.1 and 2); and Influenza A/H5 Subtyping Kit (VER 4) | OZE | 2025-07-11 | 268 |
| K243931 | CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel: Influenza A/B Typing Kit (VER 2); Influenza A Subtyping Kit (VER 4); Influenza B Lineage Genotyping Kit (VER 1.1 and 2); and Influenza A/H5 Subtyping Kit (VER 4) | OZE | 2025-03-14 | 84 |
| K241110 | CDC Human Influenza Virus Real-Time RT-PCR Diagnostic Panel, Influenza A Subtyping Kit (Ver4) | OZE | 2024-05-21 | 29 |
| K222558 | Non-variola Orthopoxvirus Real-time PCR Primer and Probe Set | PBK | 2022-08-30 | 6 |
| K221834 | Non-variola Orthopoxvirus Real-time PCR Primer and Probe Set | PBK | 2022-06-24 | 1 |
| K221658 | Non-variola Orthopoxvirus Real-time PCR Primer and Probe Set | PBK | 2022-06-10 | 2 |
| K200370 | CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel, Influenza A/B Typing Kit, CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel, Influenza A Subtyping Kit, CDC Human Influenza Virus Real-time RT-PCR, Influenza A/H5 Subtyping Kit | OZE | 2020-03-10 | 25 |
| K192871 | B. anthracis Real-time PCR Assay | NHT | 2019-11-07 | 30 |
16 earlier clearances. See the full list in Caduvo.
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| DEN070001 | De Novo | Non-Variola Orthopoxvirus Real-Time Pcr Primer And Probe Set | 2018-09-21 |
| DEN130005 | De Novo | Organophosphate Test System | 2013-08-08 |
| DEN120012 | De Novo | Dengue Nucleic Acid Amplification Assay (Naat) | 2012-05-24 |
| DEN060008 | De Novo | Nucleic Acid Amplification, Novel Influenza A Virus, A/H5 (Asian Lineage) Rna | 2006-02-03 |
| P820077 | PMA | AFP MID-PREGNANCY REFERENCE PREPARATION | 1984-11-30 |
Recalls
1 product recalls in 1 recall events; 1 initiated in the last five years. Most recent: 2024-04-26.
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 Centers for Disease Control and Prevention have?
Centers for Disease Control and Prevention has 26 FDA 510(k) clearances (first 1981, latest 2026), plus 1 PMA and 4 De Novo decisions, across 13 product codes in 3 review panels.
How long does FDA take to clear Centers for Disease Control and Prevention's 510(k)s?
The median time from FDA receipt to decision across Centers for Disease Control and Prevention's cleared 510(k)s is 36 days. Since 2017: 29 days, versus 84 days for all cleared 510(k)s in the same product codes.
What devices does Centers for Disease Control and Prevention make?
Its most frequent FDA product codes are OZE (Influenza A And Influenza B Multiplex Nucleic Acid Assay, 9); PBK (Non-Variola Orthopoxvirus Real-Time Pcr Primer And Probe Set, 5); OQW (2009 H1n1 Influenza Virus (Swine Origin), Nucleic Acid Or Antigen, Detection And Identification, 4).
Has Centers for Disease Control and Prevention had device recalls?
openFDA lists 1 product recall in 1 recall event by a recalling firm whose name matches Centers for Disease Control and Prevention; the most recent began 2024-04-26. Recall firm names are matched by name, so related entities filing under other names are not included.
Next steps
- See all 26 Centers for Disease Control and Prevention clearances with predicates and recalls
- Run predicate analysis for product code OZE, Centers for Disease Control and Prevention'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.