510(k) · Cleared
ClearedX100/X100HT with Full Field Peripheral Blood Smear (PBS) Application
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Scopio Labs, Ltd. · JOY Device, Automated Cell-Locating
Cleared on Jun 27, 2025 as substantially equivalent to K201301 (Scopio Labs, Ltd., 2020) and 1 other predicate after a 270-day review. Its family tree reaches back 6 generations to 1993.
- Decided
- Jun 27, 2025
- Review
- 270 days
- Class
- Class II
- Product code
- JOY
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 6 generations to K925670 (1993). No later device cites it as a predicate yet.
- Root · 6 generations backK925670 IMS-200Intelligent Medica Imaging, Inc. · 1993
- 5 generations backK003301 Diffmaster Octavia Automatic Hematology AnalyzerCellaVision AB · 2001
- 4 generations backK033840 Cellavision DM96 Automatic Hematology AnalyzerCellaVision AB · 2004 · Recalled
- 3 generations backK092116 Easycell Cell LocatorMedica Corp. · 2010
- 2 generations backK201301 X100 with Full Field Peripheral Blood Smear (PBS) ApplicationScopio Labs, Ltd. · 2020
- 1 generation backK220013 X100HT with Slide Loader with Full Field Peripheral Blood Smear…Scopio Labs, Ltd. · 2022
- This deviceK243144 X100/X100HT with Full Field Peripheral Blood Smear (PBS) ApplicationScopio Labs, Ltd. · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K925670 | IMS-200 | Intelligent Medica Imaging, Inc. | 1993 | — |
| −5 | K003301 | Diffmaster Octavia Automatic Hematology Analyzer | CellaVision AB | 2001 | — |
| −4 | K033840 | Cellavision DM96 Automatic Hematology Analyzer | CellaVision AB | 2004 | 1 |
| −3 | K092116 | Easycell Cell Locator | Medica Corp. | 2010 | — |
| −2 | K201301 | X100 with Full Field Peripheral Blood Smear (PBS) Application | Scopio Labs, Ltd. | 2020 | — |
| −1 | K220013 | X100HT with Slide Loader with Full Field Peripheral Blood Smear (PBS)… | Scopio Labs, Ltd. | 2022 | — |
| 0 (this device) | K243144 | X100/X100HT with Full Field Peripheral Blood Smear (PBS) Application | Scopio Labs, Ltd. | 2025 | — |
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 K220013 X100HT with Slide Loader with Full Field…score 7.5 · 5 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 |
|---|---|---|---|
| * | K201301 | X100 with Full Field Peripheral Blood Smear (PBS) ApplicationSummary page 6…e Name: X100 / X100HT with Full Field Peripheral Blood Smear Application Device 510(k): K201301, K220013 Manufacturer Scopio Labs Ltd. IV. Device Description The X100 / X100HT with Full F… | 2020 |
| * | K220013 | X100HT with Slide Loader with Full Field Peripheral Blood Smear (PBS) ApplicationSummary page 6…X100 / X100HT with Full Field Peripheral Blood Smear Application Device 510(k): K201301, K220013 Manufacturer Scopio Labs Ltd. IV. Device Description The X100 / X100HT with Full Field Peri… | 2022 |
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 32 years and passes through 4 companies; a new generation was cleared every 6.3 years on median.
- 1 of the 6 ancestors has a recall of any class.
- 1 other device also cites its predicate K201301.
How does its category compare?
All JOY devicesJOY Device, Automated Cell-Locating: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, 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 X100/X100HT with Full Field Peripheral Blood Smear Application is intended to locate and display images of white
cells, red cells, and platelets acquired from fixed and stained peripheral blood smears and assists a qualified technologist
in conducting a WBC differential, RBC morphology evaluation, and platelet estimate using those images. For in-vitro
diagnostic use only. For professional use only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K243144 · printed Nov 6, 2026
Cite this page
510(k) Report. “K243144: X100/X100HT with Full Field Peripheral Blood Smear (PBS) Application.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K243144
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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