510(k) · Cleared
ClearedAdvanced RBC 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 Aug 1, 2017 as substantially equivalent to K033840 (CellaVision AB, 2004) and 1 other predicate after an 89-day review. Its family tree reaches back 4 generations to 1993.
- Decided
- Aug 1, 2017
- Review
- 89 days
- Class
- Class II
- Product code
- JOY
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K925670 (1993). No later device cites it as a predicate yet.
- 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 deviceK171315 Advanced RBC ApplicationCellaVision AB · 2017
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) | K171315 | Advanced RBC Application | CellaVision AB | 2017 | — |
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? (3)
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 4…procedure). b) RBC functionality of the Peripheral Blood Application of the CellaVision DM Software installed on the legally marketed DM Systems, DM96 (K033840) and DM1200 (K092868). IV DEVICE DESCRIPTION The Advanced RBC Application is substantially equivalent to the RBC… | 2004 |
| * | K092868 | Cellavision DM1200 Automated Hematology Analyzer, Model XU-10127Summary page 4…tionality of the Peripheral Blood Application of the CellaVision DM Software installed on the legally marketed DM Systems, DM96 (K033840) and DM1200 (K092868). IV DEVICE DESCRIPTION The Advanced RBC Application is substantially equivalent to the RBC functionality included in the… | 2009 |
| * | — | Romanowsky stain manual light microscope process for cell classification Named without a submission number |
What descends from it?
No later submission names this one as a predicate yet.
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 24 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.
- 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. 2017, 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?
The CellaVision DM1200 with the Advanced RBC Application is an automated cell-locating device. intended for in-vitro The CellaVision DM1200 with the Advanced RBC Application 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. The CellaVision DM1200 with the Advanced RBC Application is intended for blood samples that have been…
Read the full statement (206 words)
The CellaVision DM1200 with the Advanced RBC Application is an automated cell-locating device. intended for in-vitro
The CellaVision DM1200 with the Advanced RBC Application 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.
The CellaVision DM1200 with the Advanced RBC Application is intended for blood samples that have been flagged as abnormal by an automated cell counter.
The CellaVision DM1200 with the Advanced RBC Application is intended to be used by skilled operators, trained in the use of the device and in recognition of blood cells.
The CellaVision DM96 with the Advanced RBC Application is an automated cell-locating device, intended for in-vitro
The CellaVision DM96 with the Advanced RBC Application 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.
The CellaVision DM96 with the Advanced RBC Application is intended for blood samples that have been flagged as abnormal by an automated cell counter.
The CellaVision DM96 with the Advanced RBC Application is intended to be used by skilled operators, trained in the use of the device and in recognition of blood cells.
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/K171315 · printed Nov 6, 2026
Cite this page
510(k) Report. “K171315: Advanced RBC Application.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K171315
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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