510(k) Report

FDA applicant

CellaVision AB

Minneapolis,, MN7 decisions2001–20202 recalls

FDA records 7 decisions for CellaVision AB (Minneapolis,, MN) from 2001 to 2020: 7 510(k) clearances. All are in product code JOY (Device, Automated Cell-Locating). Its devices cite 8 predicates, 7 of them its own earlier devices. 2 recalls are linked to its devices.

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

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

How often FDA has decided CellaVision AB’s devices, and how often a recall has named them.

FDA decisions per year

1in 2020

2008: 12009: 12011: 12017: 12020: 1
2007high 1 (2008) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

1in 2025

2017: 12025: 1
2007high 1 (2017) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — CellaVision AB by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • JOYDevice, Automated Cell-Locating7decisions

Whose devices does it build on?

Its devices cite 8 predicates; 7 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 10 times; 7 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.

  • K033840Cellavision DM96 Automatic Hematology AnalyzerCellaVision AB · 20044cite it
  • K092868Cellavision DM1200 Automated Hematology Analyzer, Model XU-10127CellaVision AB · 20093cite it
  • K003301Diffmaster Octavia Automatic Hematology AnalyzerCellaVision AB · 20011cites it
  • K080595Cellavision DM96 with the Body Fluid ApplicationCellaVision AB · 20081cites it
  • K200595CellaVision DC-1, CellaVision DC-1 PPACellaVision AB · 20201cites it

What has FDA decided for it lately?

  • K200595CellaVision DC-1, CellaVision DC-1 PPACellaVision AB · 2020
  • K171315Advanced RBC ApplicationCellaVision AB · 2017
  • K102778Cellavision DM1200 with the Body Fluid ApplictionCellaVision AB · 2011
  • K092868Cellavision DM1200 Automated Hematology Analyzer, Model XU-10127CellaVision AB · 20092 recalls
  • K080595Cellavision DM96 with the Body Fluid ApplicationCellaVision AB · 2008
  • K033840Cellavision DM96 Automatic Hematology AnalyzerCellaVision AB · 20041 recall
  • K003301Diffmaster Octavia Automatic Hematology AnalyzerCellaVision AB · 2001

All 7 as CellaVision AB →

What has been recalled?

2 recalls linked to its devices; the latest:

  • K092868REF: CC286297 or BS737162 Automated Digital Cell Morphology analyzer DI-60, IVD in…Oct 8, 2025Class II
  • K033840CellaVision DM Software versions 6.0.1 or 6.0.2 installed on the following products…Dec 4, 2017Class II