510(k) · Cleared
Recalled · Class II · 2017Cellavision DM96 Automatic Hematology Analyzer
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 Feb 10, 2004 as substantially equivalent to K003301 (CellaVision AB, 2001) after a 62-day review. Its family tree reaches back 2 generations to 1993. 11 later devices descend from it. It has been recalled once.
- Decided
- Feb 10, 2004
- Review
- 62 days
- Class
- Class II
- Product code
- JOY
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 2 generations to K925670 (1993). 11 later devices descend from it, 4 citing it directly.
- Root · 2 generations backK925670 IMS-200Intelligent Medica Imaging, Inc. · 1993
- 1 generation backK003301 Diffmaster Octavia Automatic Hematology AnalyzerCellaVision AB · 2001
- This deviceK033840 Cellavision DM96 Automatic Hematology AnalyzerCellaVision AB · 2004
- Descendant · cites it directly · 4 of its ownK092868 Cellavision DM1200 Automated Hematology Analyzer, Model XU-10127CellaVision AB · 2009 · Recalled
- Descendant · cites it directly · 3 of its ownK092116 Easycell Cell LocatorMedica Corp. · 2010
- Descendant · 2 generations on · 2 of its ownK201301 X100 with Full Field Peripheral Blood Smear (PBS) ApplicationScopio Labs, Ltd. · 2020
- Descendant · 3 generations on · 1 of its ownK220013 X100HT with Slide Loader with Full Field Peripheral Blood Smear…Scopio Labs, Ltd. · 2022
- Descendant · 2 generations on · 1 of its ownK200595 CellaVision DC-1, CellaVision DC-1 PPACellaVision AB · 2020
Showing 5 of 11 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 11 · See all- K092868Cellavision DM1200 Automated Hematology Analyzer, Model XU-10127CellaVision AB · 2009 · cites it directly4descendants
- K092116Easycell Cell LocatorMedica Corp. · 2010 · cites it directly3descendants
- K201301X100 with Full Field Peripheral Blood Smear (PBS) ApplicationScopio Labs, Ltd. · 2020 · 2 generations on2descendants
- K220013X100HT with Slide Loader with Full Field Peripheral Blood Smear (PBS) ApplicationScopio Labs, Ltd. · 2022 · 3 generations on1descendant
- K200595CellaVision DC-1, CellaVision DC-1 PPACellaVision AB · 2020 · 2 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K925670 | IMS-200 | Intelligent Medica Imaging, Inc. | 1993 | — |
| −1 | K003301 | Diffmaster Octavia Automatic Hematology Analyzer | CellaVision AB | 2001 | — |
| 0 (this device) | K033840 | Cellavision DM96 Automatic Hematology Analyzer | CellaVision AB | 2004 | — |
| +1 | K092868 | Cellavision DM1200 Automated Hematology Analyzer, Model XU-10127 | CellaVision AB | 2009 | 2 |
| +1 | K092116 | Easycell Cell Locator | Medica Corp. | 2010 | — |
| +2 | K201301 | X100 with Full Field Peripheral Blood Smear (PBS) Application | Scopio Labs, Ltd. | 2020 | — |
| +3 | K220013 | X100HT with Slide Loader with Full Field Peripheral Blood Smear (PBS)… | Scopio Labs, Ltd. | 2022 | — |
| +2 | K200595 | CellaVision DC-1, CellaVision DC-1 PPA | CellaVision AB | 2020 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2020 | 2 | 0 |
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2025 | 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 |
|---|---|---|---|
| * | K003301 | Diffmaster Octavia Automatic Hematology AnalyzerSummary page 1…copic process for cell classification (21CFR 864.3600 Class I exempted from premarket notification procedure) and DiffMaster OctaviaTM Hematology Analyzer, 510(k) number K003301, CellaVision AB. 3. Description of the device DM96 is an automated cell-locating device for differential count of white blood ce… | 2001 |
| * | — | Romanowsky stain manual light microscopic process Named without a submission number |
What descends from it? (11)
See all 114 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Dec 4, 2017 | Class II | Z-2184-2018 | Software design | A software malfunction was found where WBC, RBC and PLT comments added after a slide is signed, are not sent to the LIS. This can only occur where customers process multiple slides per blood sample. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 11 years and passes through 2 companies; a new generation was cleared every 7.6 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K092868 (CellaVision AB, 2009) has gone furthest, with 4 descendants of its own.
How does its category compare?
All JOY devicesJOY Device, Automated Cell-Locating: FDA decisions, review times, recalls and adverse event reports over 20 years.
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.
DM96 automatically locates and presents images of blood cells on peripheral blood smears. 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/K033840 · printed Nov 4, 2026
Cite this page
510(k) Report. “K033840: Cellavision DM96 Automatic Hematology Analyzer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K033840
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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