510(k) · Cleared
ClearedDuet System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bioview, Ltd. · JOY Device, Automated Cell-Locating
Cleared on Sep 16, 2004 as substantially equivalent to K030192 (Bioview, Ltd., 2003) and 1 other predicate after a 192-day review. Its family tree reaches back 3 generations to 1993. 12 later devices descend from it.
- Decided
- Sep 16, 2004
- Review
- 192 days
- Class
- Class II
- Product code
- JOY
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K925670 (1993). 7 ancestors in all, the oldest K902311 (1990). 12 later devices descend from it, 6 citing it directly.
- Root · 3 generations backK925670 IMS-200Intelligent Medica Imaging, Inc. · 1993
- 2 generations backK984188 Automated Cellular Imaging System (Acis)Chroma Vision Medical Systems, Inc. · 1999
- 1 generation backK030192 Duet SystemBioview, Ltd. · 2003
- This deviceK040591 Duet SystemBioview, Ltd. · 2004
- Descendant · cites it directly · 7 of its ownK050840 Modification to Duet SystemBioview, Ltd. · 2005
- Descendant · cites it directly · 5 of its ownK061602 Duet SystemBioview, Ltd. · 2007
- Descendant · cites it directly · 4 of its ownK050236 FishviewApplied Spectral Imaging, Ltd. · 2005
- Descendant · 2 generations on · 3 of its ownK071398 Scanview, Model SC-300Applied Spectral Imaging, Ltd. · 2007
- Descendant · 2 generations on · 2 of its ownK101291 Scanview HER2/Neu Fish SystemApplied Spectral Imaging, Ltd. · 2010
Showing 5 of 12 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 12 · See all- K050840Modification to Duet SystemBioview, Ltd. · 2005 · cites it directly7descendants
- K061602Duet SystemBioview, Ltd. · 2007 · cites it directly5descendants
- K050236FishviewApplied Spectral Imaging, Ltd. · 2005 · cites it directly4descendants
- K071398Scanview, Model SC-300Applied Spectral Imaging, Ltd. · 2007 · 2 generations on3descendants
- K101291Scanview HER2/Neu Fish SystemApplied Spectral Imaging, Ltd. · 2010 · 2 generations on2descendants
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 | K984188 | Automated Cellular Imaging System (Acis) | Chroma Vision Medical Systems, Inc. | 1999 | — |
| −1 | K030192 | Duet System | Bioview, Ltd. | 2003 | — |
| 0 (this device) | K040591 | Duet System | Bioview, Ltd. | 2004 | — |
| +1 | K050840 | Modification to Duet System | Bioview, Ltd. | 2005 | — |
| +1 | K061602 | Duet System | Bioview, Ltd. | 2007 | — |
| +1 | K050236 | Fishview | Applied Spectral Imaging, Ltd. | 2005 | — |
| +2 | K071398 | Scanview, Model SC-300 | Applied Spectral Imaging, Ltd. | 2007 | — |
| +2 | K101291 | Scanview HER2/Neu Fish System | Applied Spectral Imaging, Ltd. | 2010 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 1 | 0 |
| 1995 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 2 | 0 |
| 2006 | 2 | 0 |
| 2007 | 3 | 0 |
| 2008 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 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? (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 |
|---|---|---|---|
| * | K030192 | Duet SystemSummary page 2…by the Pathology Panel. I Predicate Device: * DuetTM System, manufactured by BioView, cleared under K030192 * BandView, manufactured by Applied Spectral Imaging, cleared under K012103. * Human manual visualization by co… | 2003 |
| * | K012103 | Bandview SystemSummary page 2…= Predicate Device: * DuetTM System, manufactured by BioView, cleared under K030192 * BandView, manufactured by Applied Spectral Imaging, cleared under K012103. * Human manual visualization by conventional microscope. Performance Standards: No performance standards have been… | 2001 |
| * | — | Human manual visualization by conventional microscope Named without a submission number |
What descends from it? (12)
See all 126 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 11 years and passes through 3 companies; a new generation was cleared every 4.1 years on median.
- None of the 7 ancestors has a recall.
- Of its descendants, K050840 (Bioview, Ltd., 2005) has gone furthest, with 7 descendants of its own.
- 3 other devices also cite its predicate K030192.
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 DuetTM System is an automated scanning microscope and image analysis system. It is intended for in-vitro diagnosis use as an aiding tool to the pathologist in the detection, classification and counting of cells of interests based on particular color, intensity, size, pattern and shape.
The DuetTM System is intended to detect the following cell types:
1. Hematopoietic cells stained by Giemsa stain, lmmunohistochemistry or ISH (with bright field and fluorescent) prepared from cell suspension.
2. Amniotic cells stained by FISH (using direct labeled DNA probes for chromosomes X, Y, 13, 18 and 21).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K040591 · printed Nov 3, 2026
Cite this page
510(k) Report. “K040591: Duet System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K040591
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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