510(k) · Cleared
ClearedCellaVision DC-1, CellaVision DC-1 PPA
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 Oct 16, 2020 as substantially equivalent to K092868 (CellaVision AB, 2009) after a 224-day review. Its family tree reaches back 4 generations to 1993. 1 later device descends from it.
- Decided
- Oct 16, 2020
- Review
- 224 days
- Class
- Class II
- Product code
- JOY
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K925670 (1993). 1 later device descends from it, 1 citing it directly.
- Root · 4 generations backK925670 IMS-200Intelligent Medica Imaging, Inc. · 1993
- 3 generations backK003301 Diffmaster Octavia Automatic Hematology AnalyzerCellaVision AB · 2001
- 2 generations backK033840 Cellavision DM96 Automatic Hematology AnalyzerCellaVision AB · 2004 · Recalled
- 1 generation backK092868 Cellavision DM1200 Automated Hematology Analyzer, Model XU-10127CellaVision AB · 2009 · Recalled
- This deviceK200595 CellaVision DC-1, CellaVision DC-1 PPACellaVision AB · 2020
- Descendant · cites it directly · 0 of its ownK221309 AI100 with ShonitSigtuple Technologies Pvt., Ltd. · 2023
Most influential descendants
Showing 1 of 1 · See all- K221309AI100 with ShonitSigtuple Technologies Pvt., Ltd. · 2023 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K925670 | IMS-200 | Intelligent Medica Imaging, Inc. | 1993 | — |
| −3 | K003301 | Diffmaster Octavia Automatic Hematology Analyzer | CellaVision AB | 2001 | — |
| −2 | K033840 | Cellavision DM96 Automatic Hematology Analyzer | CellaVision AB | 2004 | 1 |
| −1 | K092868 | Cellavision DM1200 Automated Hematology Analyzer, Model XU-10127 | CellaVision AB | 2009 | 2 |
| 0 (this device) | K200595 | CellaVision DC-1, CellaVision DC-1 PPA | CellaVision AB | 2020 | — |
| +1 | K221309 | AI100 with Shonit | Sigtuple Technologies Pvt., Ltd. | 2023 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 |
|---|---|---|---|
| * | K092868 | Cellavision DM1200 Automated Hematology Analyzer, Model XU-10127Summary page 8…vice: similarities Characteristic CellaVision® DC-1 CellaVision® DM1200 K092868 Intended use CellaVision® DC-1 is an automated DM1200 is an automated cell- cell-locatin… | 2009 |
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 |
|---|---|---|---|
| K221309 | AI100 with Shonit | 2023 | 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 27 years and passes through 2 companies; a new generation was cleared every 7.6 years on median.
- 2 of the 4 ancestors have a recall of any class.
- Of its descendants, K221309 (Sigtuple Technologies Pvt., Ltd., 2023) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K092868.
How does its category compare?
All JOY devicesJOY Device, Automated Cell-Locating: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, 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?
Intended use of CellaVision® DC-1 CellaVision® DC-1 is an automated cell-locating device intended for in-vitro diagnostic use in clinical laboratories. CellaVision® DC-1 1s intended to be used by operators, trained in the use of the device. Intended use of the Peripheral Blood Application The Peripheral Blood Application is intended for differential count of white blood cells (WBC), charactenization of red blood cell (RBC) morphology and platelet…
Read the full statement (115 words)
Intended use of CellaVision® DC-1
CellaVision® DC-1 is an automated cell-locating device intended for in-vitro diagnostic
use in clinical laboratories.
CellaVision® DC-1 1s intended to be used by operators, trained in the use of the device.
Intended use of the Peripheral Blood Application
The Peripheral Blood Application is intended for differential count of white blood cells
(WBC), charactenization of red blood cell (RBC) morphology and platelet estimation.
The CellaVision® DC-1 with the Peripheral Blood Application automatically locates
blood cells on peripheral blood (PB) smears. The application presents images of the
blood cells for review. A skilled operator trained in recognition of blood cells, identifies
and venifies the suggested classification of each cell according to type.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K200595 · printed Nov 6, 2026
Cite this page
510(k) Report. “K200595: CellaVision DC-1, CellaVision DC-1 PPA.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K200595
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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