510(k) · Cleared
ClearedAI100 with Shonit
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sigtuple Technologies Pvt., Ltd. · JOY Device, Automated Cell-Locating
Cleared on Sep 19, 2023 as substantially equivalent to K200595 (CellaVision AB, 2020) after a 502-day review. Its family tree reaches back 5 generations to 1993.
- Decided
- Sep 19, 2023
- Review
- 502 days
- Class
- Class II
- Product code
- JOY
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K925670 (1993). No later device cites it as a predicate yet.
- Root · 5 generations backK925670 IMS-200Intelligent Medica Imaging, Inc. · 1993
- 4 generations backK003301 Diffmaster Octavia Automatic Hematology AnalyzerCellaVision AB · 2001
- 3 generations backK033840 Cellavision DM96 Automatic Hematology AnalyzerCellaVision AB · 2004 · Recalled
- 2 generations backK092868 Cellavision DM1200 Automated Hematology Analyzer, Model XU-10127CellaVision AB · 2009 · Recalled
- 1 generation backK200595 CellaVision DC-1, CellaVision DC-1 PPACellaVision AB · 2020
- This deviceK221309 AI100 with ShonitSigtuple Technologies Pvt., Ltd. · 2023
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K925670 | IMS-200 | Intelligent Medica Imaging, Inc. | 1993 | — |
| −4 | K003301 | Diffmaster Octavia Automatic Hematology Analyzer | CellaVision AB | 2001 | — |
| −3 | K033840 | Cellavision DM96 Automatic Hematology Analyzer | CellaVision AB | 2004 | 1 |
| −2 | K092868 | Cellavision DM1200 Automated Hematology Analyzer, Model XU-10127 | CellaVision AB | 2009 | 2 |
| −1 | K200595 | CellaVision DC-1, CellaVision DC-1 PPA | CellaVision AB | 2020 | — |
| 0 (this device) | K221309 | AI100 with Shonit | Sigtuple Technologies Pvt., Ltd. | 2023 | — |
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 |
|---|---|---|---|
| * | K200595 | CellaVision DC-1, CellaVision DC-1 PPASummary page 7…icate device. See below for the substantial equivalence comparisons. Table 1: Comparison with Predicate Device: Similarities Characteristic CellaVision® DC-1 (K200595) AI100 with ShonitTM (K221309) Intended Use CellaVision® DC-1 is an automated AI100 with ShonitTM i… | 2020 |
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 30 years and passes through 3 companies; a new generation was cleared every 5.8 years on median.
- 2 of the 5 ancestors have a recall of any class.
How does its category compare?
All JOY devicesJOY Device, Automated Cell-Locating: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, 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?
AI100 with ShonitTM is a cell locating device intended for in-vitro diagnostic use in clinical laboratories.
AI100 with ShonitTM is intended for differential count of White Blood Cells (WBC), characterization of Red Blood Cells (RBC) morphology and Platelet morphology. It automatically locates blood cells on peripheral blood smears and presents images of the blood cells for review.
A skilled operator, trained in the use of the device and in the review of blood cells, identifies and classifies each cell according to type.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K221309 · printed Nov 6, 2026
Cite this page
510(k) Report. “K221309: AI100 with Shonit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K221309
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