510(k) Report

510(k) · Cleared

Cleared

Slidescan

K001420510(k) TraditionalCleared Aug 30, 2000117-day reviewClass II21 CFR 864.5260

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Applied Imaging Corp. · JOY Device, Automated Cell-Locating

Cleared on Aug 30, 2000 after a 117-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 14 later devices descend from it.

Decided
Aug 30, 2000
Review
117 days
Class
Class II
Product code
JOY
Recalls
None
Predicates
0

14 later devices descend from it, 1 citing it directly.

Descendants, by year cleared 2003: 1 descendant cleared2014: 1 descendant cleared2004: 1 descendant cleared2007: 3 descendants cleared2005: 2 descendants cleared2006: 2 descendants cleared2011: 1 descendant cleared2008: 1 descendant cleared2010: 1 descendant cleared2013: 1 descendant cleared200020052010201520202025
  1. This deviceK001420 SlidescanApplied Imaging Corp. · 2000
  2. Descendant · cites it directly · 13 of its ownK030192 Duet SystemBioview, Ltd. · 2003
  3. Descendant · 2 generations on · 12 of its ownK040591 Duet SystemBioview, Ltd. · 2004
  4. Descendant · 2 generations on · 7 of its ownK050840 Modification to Duet SystemBioview, Ltd. · 2005
  5. Descendant · 2 generations on · 5 of its ownK061602 Duet SystemBioview, Ltd. · 2007
  6. Descendant · 3 generations on · 4 of its ownK050236 FishviewApplied Spectral Imaging, Ltd. · 2005

Showing 5 of 14 descendants. See all descendants

Descendants cleared per year

2003: 12004: 12005: 22006: 22007: 32008: 12010: 12011: 12013: 12014: 1
2003high 3 (2007) · low 0 (2009)2026

Most influential descendants

Showing 5 of 14 · See all
  • K030192Duet SystemBioview, Ltd. · 2003 · cites it directly13descendants
  • K040591Duet SystemBioview, Ltd. · 2004 · 2 generations on12descendants
  • K050840Modification to Duet SystemBioview, Ltd. · 2005 · 2 generations on7descendants
  • K061602Duet SystemBioview, Ltd. · 2007 · 2 generations on5descendants
  • K050236FishviewApplied Spectral Imaging, Ltd. · 2005 · 3 generations on4descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K001420SlidescanApplied Imaging Corp.2000—
+1K030192Duet SystemBioview, Ltd.2003—
+2K040591Duet SystemBioview, Ltd.2004—
+2K050840Modification to Duet SystemBioview, Ltd.2005—
+2K061602Duet SystemBioview, Ltd.2007—
+3K050236FishviewApplied Spectral Imaging, Ltd.2005—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200310
200410
200520
200620
200730
200810
201010
201110
201310
201410
FIG. 1 — Lineage of K001420, 2000–2014Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), 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. #1 K243144 X100/X100HT with Full Field Peripheral Blood…score 11.1 · 6 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (14)

See all 14

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K030192Duet SystemBioview, Ltd.200313

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?

  • Of its descendants, K030192 (Bioview, Ltd., 2003) has gone furthest, with 13 descendants of its own.

How does its category compare?

All JOY devices

JOY Device, Automated Cell-Locating: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · JOY

1in 2025

2007: 32008: 12009: 12010: 12011: 12017: 12018: 12020: 22022: 12023: 12025: 1
2007high 3 (2007) · low 0 (2012)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · JOY

136in 2007

2007: 136 days median
2007high 136 (2007)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · JOY

1in 2025

2025: 1
2007high 1 (2025) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · JOY

1in 2025

2017: 42019: 32022: 22024: 52025: 1
2007high 5 (2024) · low 0 (2007)2025

MAUDE reports naming product code JOY, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
2007313600
20081—00
20091—00
20101—00
20111—00
20120—00
20130—00
20140—00
20150—00
20160—00
20171—04
20181—00
20190—03
20202—00
20210—00
20221—02
20231—00
20240—05
20251—11
20260—0—
Cite this page

510(k) Report. “K001420: Slidescan.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K001420

Report an extraction error

Tell us what is wrong; we check it against the FDA summary.

Are you the manufacturer?

Send a correction or an update to this page, for example a newer model or a public statement about a recall.

Record history
  • FDA decision record loaded May 2, 2026
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026