510(k) Report

FDA applicant

Centers for Disease Control and Prevention

Atlanta, GA33 decisions1981–20261 recall

FDA records 33 decisions for Centers for Disease Control and Prevention (Atlanta, GA) from 1981 to 2026: 28 510(k) clearances, 4 De Novo grants and 1 original PMA approval. Most are in product codes OZE (Influenza A And Influenza B Multiplex Nucleic…) and PBK (Non-Variola Orthopoxvirus Real-Time Pcr Primer…). Since 2016 its 510(k)s took a median of 4 days from receipt to decision, against 2 for FDA’s reviews in the same codes and years. Its devices cite 29 predicates, 22 of them its own earlier devices. 1 recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, microbiology panel, where it files most

How often FDA has decided Centers for Disease Control and Prevention’s devices, and how often a recall has named them.

FDA decisions per year

3in 2025

2008: 12010: 12011: 12012: 12013: 42014: 32017: 12018: 22019: 22020: 12022: 32024: 12025: 32026 (partial year): 3
2007high 4 (2013) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

1in 2024

2024: 1
2007high 1 (2024) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Centers for Disease Control and Prevention by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Centers for Disease Control and…’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Which product codes does it file in?

  • OZEInfluenza A And Influenza B Multiplex Nucleic Acid Assay10decisions
  • PBKNon-Variola Orthopoxvirus Real-Time Pcr Primer And Probe Set5decisions
  • OQW2009 H1n1 Influenza Virus (Swine Origin), Nucleic Acid Or Antigen, Detection And…4decisions
  • LHLReagents, Antibody, Legionella, Direct & Indirect Fluorescent2decisions
  • SGABiothreat Microbial Agent Nucleic Acid Detection Test2decisions
  • NHTAssay, Nucleic Acid Amplification, Bacillus Anthracis2decisions

Also: NXD (2), LTQ (1), GMQ (1), OEP (1), OZB (1), PDY (1).

How long do its 510(k) reviews take?

Since 2016, its 4 510(k)s took a median of 4 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 2 days; 1 of its 4 were faster than that.

Whose devices does it build on?

Its devices cite 29 predicates; 22 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 33 times; 22 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K080570CDC Human Influenza Virus Real-Time RT- PCR Detection and Characterization PanelCenters for Disease Control and Prevention · 20088cite it
  • K132508CDC Human Influenza Virus Real-Time RT-PCR Diagnostic PanelCenters for Disease Control and Prevention · 20134cite it
  • K190302CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel, Influenza A/B Typing Kit, CDC Human Influenza…Centers for Disease Control and Prevention · 20192cite it
  • K111507CDC Human Influenza Virus Real-Time RT-PCR Diagnostic PanelCenters for Disease Control and Prevention · 20112cite it
  • K172091CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel, Influenza A/B Typing Kit, CDC Human Influenza…Centers for Disease Control and Prevention · 20172cite it
  • DEN060008Influenza a/H5 (Asian Lineage) Virus Real-Time RT-PCR Primer and Probe SetCenters for Disease Control and Prevention · 20062cite it

What has FDA decided for it lately?

  • K262368B. anthracis Real-time PCR AssayCenters for Disease Control and Prevention · 2026
  • K263035CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel (includes Influenza A/B Typing Kit, Influenza A…Centers for Disease Control and Prevention · 2026
  • K260812Francisella tularensis Real-time PCR AssayCenters for Disease Control and Prevention · 2026
  • K252072Francisella tularensis Real-time PCR assayCenters for Disease Control and Prevention · 2025
  • K243274CDC Human Influenza Virus Real-Time RT-PCR Diagnostic Panel: Influenza A/B Typing Kit (VER 2); Influenza A…Centers for Disease Control and Prevention · 2025
  • K243931CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel: Influenza A/B Typing Kit (VER 2); Influenza A…Centers for Disease Control and Prevention · 2025
  • K241110CDC Human Influenza Virus Real-Time RT-PCR Diagnostic Panel, Influenza A Subtyping Kit (Ver4)Centers for Disease Control and Prevention · 2024
  • K222558Non-variola Orthopoxvirus Real-time PCR Primer and Probe SetCenters for Disease Control and Prevention · 2022

All 33 as Centers for Disease Control and Prevention →

What has been recalled?

1 recall linked to its devices; the latest:

  • K200370CDC, Influenza A/H5 Subtyping Kit, Model/Catalog Number: FluIVD03-11Apr 26, 2024Class II

Other applicant names beginning “Centers”

FDA records each applicant name separately; these may or may not be the same firm.

Centers For Disease Control and Prevention (CDC) 6