510(k) · Cleared
ClearedEasycell Cell Locator
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medica Corp. · JOY Device, Automated Cell-Locating
Cleared on May 12, 2010 as substantially equivalent to K033840 (CellaVision AB, 2004) after a 302-day review. Its family tree reaches back 3 generations to 1993. 3 later devices descend from it.
- Decided
- May 12, 2010
- Review
- 302 days
- Class
- Class II
- Product code
- JOY
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K925670 (1993). 3 later devices descend from it, 1 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 deviceK092116 Easycell Cell LocatorMedica Corp. · 2010
- Descendant · cites it directly · 2 of its ownK201301 X100 with Full Field Peripheral Blood Smear (PBS) ApplicationScopio Labs, Ltd. · 2020
- Descendant · 2 generations on · 1 of its ownK220013 X100HT with Slide Loader with Full Field Peripheral Blood Smear…Scopio Labs, Ltd. · 2022
- Descendant · 2 generations on · 0 of its ownK243144 X100/X100HT with Full Field Peripheral Blood Smear (PBS) ApplicationScopio Labs, Ltd. · 2025
Most influential descendants
Showing 3 of 3 · See all- K201301X100 with Full Field Peripheral Blood Smear (PBS) ApplicationScopio Labs, Ltd. · 2020 · cites it directly2descendants
- K220013X100HT with Slide Loader with Full Field Peripheral Blood Smear (PBS) ApplicationScopio Labs, Ltd. · 2022 · 2 generations on1descendant
- K243144X100/X100HT with Full Field Peripheral Blood Smear (PBS) ApplicationScopio Labs, Ltd. · 2025 · 2 generations on0descendants
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) | K092116 | Easycell Cell Locator | Medica Corp. | 2010 | — |
| +1 | K201301 | X100 with Full Field Peripheral Blood Smear (PBS) Application | Scopio Labs, Ltd. | 2020 | — |
| +2 | K220013 | X100HT with Slide Loader with Full Field Peripheral Blood Smear (PBS)… | Scopio Labs, Ltd. | 2022 | — |
| +2 | K243144 | X100/X100HT with Full Field Peripheral Blood Smear (PBS) Application | Scopio Labs, Ltd. | 2025 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 1 | 0 |
| 2022 | 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? (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…mation Manufacturer: CellaVision AB, Lund, Sweden Product: CeliaVision DM96 Automatic Hematology Analyzer 5 10O(k) number: K033840 4. Intended Use The EasyCell is intended to locate and display images of white cells, red cells, and platelets acquired from… | 2004 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K201301 | X100 with Full Field Peripheral Blood Smear (PBS) Application | 2020 | 2 |
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 17 years and passes through 3 companies; a new generation was cleared every 6.3 years on median.
- 1 of the 3 ancestors has a recall of any class.
- Of its descendants, K201301 (Scopio Labs, Ltd., 2020) has gone furthest, with 2 descendants 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. 2010, 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 EasyCell 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/K092116 · printed Nov 6, 2026
Cite this page
510(k) Report. “K092116: Easycell Cell Locator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K092116
Report an extraction error
Are you the manufacturer?
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