510(k) · Cleared
ClearedMICRO21 with Retic
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Triangle Biomedical Sciences, Inc. · JOY Device, Automated Cell-Locating
Cleared on May 17, 1996 as substantially equivalent to K925670 (Intelligent Medica Imaging, Inc., 1993) after an 81-day review. Its family tree reaches back 1 generation to 1993.
- Decided
- May 17, 1996
- Review
- 81 days
- Class
- Class II
- Product code
- JOY
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K925670 (1993). No later device cites it as a predicate yet.
- Root · 1 generation backK925670 IMS-200Intelligent Medica Imaging, Inc. · 1993
- This deviceK960776 MICRO21 with ReticTriangle Biomedical Sciences, Inc. · 1996
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K925670 | IMS-200 | Intelligent Medica Imaging, Inc. | 1993 | — |
| 0 (this device) | K960776 | MICRO21 with Retic | Triangle Biomedical Sciences, Inc. | 1996 | — |
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 |
|---|---|---|---|
| * | K925670 | IMS-200Summary page 1…: Automated Cell Locating Device Classification Number: 81JOY Class: I Regulation Number: 864.5260 The MICRO2I™ with WBC Diff (White Blood Cell Differential) Ref. No. K925670/A is an automated microscopic system that locates WBCs, stores digital images of the cells and displays the images in an organize… | 1993 |
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?
- Its one ancestor has no recall.
- 4 other devices also cite its predicate K925670.
How does its category compare?
All JOY devicesJOY Device, Automated Cell-Locating: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 MICRO21 with Retic is a new MICRO21 intended use that follows the same process as the MICRO21 with WBC Diff, but instead locates, digitally stores and displays reticulated red blood cells (retics) to aid the technologist in performing the Reticulocyte Count procedure.
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/K960776 · printed Nov 5, 2026
Cite this page
510(k) Report. “K960776: MICRO21 with Retic.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K960776
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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