510(k) · Cleared
ClearedCellavision DM96 with the Body Fluid Application
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
CellaVision AB · JOY Device, Automated Cell-Locating
Cleared on Dec 5, 2008 as substantially equivalent to K033840 (CellaVision AB, 2004) after a 277-day review. Its family tree reaches back 3 generations to 1993. 1 later device descends from it.
- Decided
- Dec 5, 2008
- Review
- 277 days
- Class
- Class II
- Product code
- JOY
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K925670 (1993). 1 later device descends from it, 1 citing it directly.
- Root · 3 generations backK925670 IMS-200Intelligent Medica Imaging, Inc. · 1993
- 2 generations backK003301 Diffmaster Octavia Automatic Hematology AnalyzerCellaVision AB · 2001
- 1 generation backK033840 Cellavision DM96 Automatic Hematology AnalyzerCellaVision AB · 2004 · Recalled
- This deviceK080595 Cellavision DM96 with the Body Fluid ApplicationCellaVision AB · 2008
- Descendant · cites it directly · 0 of its ownK102778 Cellavision DM1200 with the Body Fluid ApplictionCellaVision AB · 2011
Most influential descendants
Showing 1 of 1 · See all- K102778Cellavision DM1200 with the Body Fluid ApplictionCellaVision AB · 2011 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K925670 | IMS-200 | Intelligent Medica Imaging, Inc. | 1993 | — |
| −2 | K003301 | Diffmaster Octavia Automatic Hematology Analyzer | CellaVision AB | 2001 | — |
| −1 | K033840 | Cellavision DM96 Automatic Hematology Analyzer | CellaVision AB | 2004 | 1 |
| 0 (this device) | K080595 | Cellavision DM96 with the Body Fluid Application | CellaVision AB | 2008 | — |
| +1 | K102778 | Cellavision DM1200 with the Body Fluid Appliction | CellaVision AB | 2011 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in JOY? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new JOY device
- #1 K243144 X100/X100HT with Full Field Peripheral Blood…score 11.1 · 6 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K033840 | Cellavision DM96 Automatic Hematology AnalyzerSummary page 1…follows the same process as the currently cleared DM96 with white blood cell differential, RBC characterization and platelet estimation (K033840). Intended Use: DM96 is an automated cell-locating device. The body fluid application is intended for dif… | 2004 |
| * | — | Romanowsky stain manual light microscopic process for cell classification Named without a submission number |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K102778 | Cellavision DM1200 with the Body Fluid Appliction | 2011 | 0 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 15 years and passes through 2 companies; a new generation was cleared every 4.8 years on median.
- 1 of the 3 ancestors has a recall of any class.
- Of its descendants, K102778 (CellaVision AB, 2011) has gone furthest, with 0 descendants of its own.
- 3 other devices also cite its predicate K033840.
How does its category compare?
All JOY devicesJOY Device, Automated Cell-Locating: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.
FDA decisions per year · JOY
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · JOY
136in 2007
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · JOY
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JOY
1in 2025
MAUDE reports naming product code JOY, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 3 | 136 | 0 | 0 |
| 2008 | 1 | — | 0 | 0 |
| 2009 | 1 | — | 0 | 0 |
| 2010 | 1 | — | 0 | 0 |
| 2011 | 1 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 1 | — | 0 | 4 |
| 2018 | 1 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 3 |
| 2020 | 2 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 1 | — | 0 | 2 |
| 2023 | 1 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 5 |
| 2025 | 1 | — | 1 | 1 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
DM96 is an automated cell-locating device.
The body fluid application is intended for differential count of white blood cells. The system automatically locates and presents images of cells on cytocentrifuged body fluid preparations. The operator identifies and verifies the suggested classification of each cell according to type.
DM96 is intended to be used by skilled operators, trained in the use of the device and in recognition of blood cells.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K080595 · printed Nov 3, 2026
Cite this page
510(k) Report. “K080595: Cellavision DM96 with the Body Fluid Application.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K080595
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026