510(k) · Cleared
Recalled · Class II · 2025Cellavision DM1200 Automated Hematology Analyzer, Model XU-10127
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 Nov 20, 2009 as substantially equivalent to K033840 (CellaVision AB, 2004) after a 63-day review. Its family tree reaches back 3 generations to 1993. 4 later devices descend from it. It has been recalled 2 times.
- Decided
- Nov 20, 2009
- Review
- 63 days
- Class
- Class II
- Product code
- JOY
- Recalls
- 2
- Predicates
- 1
Its longest line of descent runs back 3 generations to K925670 (1993). 4 later devices descend from it, 3 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 deviceK092868 Cellavision DM1200 Automated Hematology Analyzer, Model XU-10127CellaVision AB · 2009
- Descendant · cites it directly · 1 of its ownK200595 CellaVision DC-1, CellaVision DC-1 PPACellaVision AB · 2020
- Descendant · 2 generations on · 0 of its ownK221309 AI100 with ShonitSigtuple Technologies Pvt., Ltd. · 2023
- Descendant · cites it directly · 0 of its ownK171655 cobas m 511 integrated hematology analyzerRoche Diagnostics Hematology, Inc. · 2018 · Recalled
- Descendant · cites it directly · 0 of its ownK171315 Advanced RBC ApplicationCellaVision AB · 2017
Most influential descendants
Showing 4 of 4 · See all- K200595CellaVision DC-1, CellaVision DC-1 PPACellaVision AB · 2020 · cites it directly1descendant
- K221309AI100 with ShonitSigtuple Technologies Pvt., Ltd. · 2023 · 2 generations on0descendants
- K171655cobas m 511 integrated hematology analyzerRoche Diagnostics Hematology, Inc. · 2018 · cites it directly0descendants
- K171315Advanced RBC ApplicationCellaVision AB · 2017 · 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) | K092868 | Cellavision DM1200 Automated Hematology Analyzer, Model XU-10127 | CellaVision AB | 2009 | — |
| +1 | K200595 | CellaVision DC-1, CellaVision DC-1 PPA | CellaVision AB | 2020 | — |
| +2 | K221309 | AI100 with Shonit | Sigtuple Technologies Pvt., Ltd. | 2023 | — |
| +1 | K171655 | cobas m 511 integrated hematology analyzer | Roche Diagnostics Hematology, Inc. | 2018 | 1 |
| +1 | K171315 | Advanced RBC Application | CellaVision AB | 2017 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2020 | 1 | 0 |
| 2023 | 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? (1)
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…JOY; GKZ Code: Predicate CellaVision AB believes that DM1200 is substantially equivalent to the legally Device . marketed (unmodified) device DM96 (K(033840) regarding technology and Identification: function. Device DM1 200 is an automated cell-locating device for diffe… | 2004 |
What descends from it? (4)
3 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 |
|---|---|---|---|---|
| Oct 8, 2025 | Class II | Z-0542-2026 | Software design | Automated cell-locating device barcode reader may read the barcode of the previously processed slide resulting in a misattribution of diagnostic results. |
| 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 16 years and passes through 2 companies; a new generation was cleared every 5.8 years on median.
- 1 of the 3 ancestors has a recall of any class.
- Of its descendants, K200595 (CellaVision AB, 2020) has gone furthest, with 1 descendant 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. 2009, 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?
DM1200 is an automated cell-locating device.
DM1200 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.
DM1200 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/K092868 · printed Nov 6, 2026
Cite this page
510(k) Report. “K092868: Cellavision DM1200 Automated Hematology Analyzer, Model XU-10127.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K092868
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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