510(k) Report

510(k) · Cleared

Cleared

Diffmaster Octavia Automatic Hematology Analyzer

K003301510(k) TraditionalCleared Mar 15, 2001146-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

CellaVision AB · JOY Device, Automated Cell-Locating

Cleared on Mar 15, 2001 as substantially equivalent to K925670 (Intelligent Medica Imaging, Inc., 1993) after a 146-day review. Its family tree reaches back 1 generation to 1993. 12 later devices descend from it.

Decided
Mar 15, 2001
Review
146 days
Class
Class II
Product code
JOY
Recalls
None
Predicates
1

Its longest line of descent runs back 1 generation to K925670 (1993). 12 later devices descend from it, 1 citing it directly.

Descendants, by year cleared 2004: 1 descendant cleared2017: 1 descendant cleared2010: 1 descendant cleared2008: 1 descendant cleared2009: 1 descendant cleared2011: 1 descendant cleared2020: 2 descendants cleared2018: 1 descendant cleared2023: 1 descendant cleared2022: 1 descendant cleared2025: 1 descendant clearedK925670 · IMS-200 · Intelligent Medica Imaging, Inc. · 19931990200020102020
Descendants, by generation 1 generation forward: 1 descendant2 generations forward: 4 descendants3 generations forward: 4 descendants4 generations forward: 3 descendants K925670 · IMS-200 · Intelligent Medica Imaging, Inc. · 19930
  1. Root · 1 generation backK925670 IMS-200Intelligent Medica Imaging, Inc. · 1993
  2. This deviceK003301 Diffmaster Octavia Automatic Hematology AnalyzerCellaVision AB · 2001
  3. Descendant · cites it directly · 11 of its ownK033840 Cellavision DM96 Automatic Hematology AnalyzerCellaVision AB · 2004 · Recalled
  4. Descendant · 2 generations on · 4 of its ownK092868 Cellavision DM1200 Automated Hematology Analyzer, Model XU-10127CellaVision AB · 2009 · Recalled
  5. Descendant · 2 generations on · 3 of its ownK092116 Easycell Cell LocatorMedica Corp. · 2010
  6. Descendant · 3 generations on · 2 of its ownK201301 X100 with Full Field Peripheral Blood Smear (PBS) ApplicationScopio Labs, Ltd. · 2020
  7. Descendant · 4 generations on · 1 of its ownK220013 X100HT with Slide Loader with Full Field Peripheral Blood Smear…Scopio Labs, Ltd. · 2022

Showing 5 of 12 descendants. See all descendants

Descendants cleared per year

2004: 12008: 12009: 12010: 12011: 12017: 12018: 12020: 22022: 12023: 12025: 1
2004high 2 (2020) · low 0 (2005)2026

Most influential descendants

Showing 5 of 12 · See all
  • K033840Cellavision DM96 Automatic Hematology AnalyzerCellaVision AB · 2004 · cites it directly11descendants
  • K092868Cellavision DM1200 Automated Hematology Analyzer, Model XU-10127CellaVision AB · 2009 · 2 generations on4descendants
  • K092116Easycell Cell LocatorMedica Corp. · 2010 · 2 generations on3descendants
  • K201301X100 with Full Field Peripheral Blood Smear (PBS) ApplicationScopio Labs, Ltd. · 2020 · 3 generations on2descendants
  • K220013X100HT with Slide Loader with Full Field Peripheral Blood Smear (PBS) ApplicationScopio Labs, Ltd. · 2022 · 4 generations on1descendant
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K925670IMS-200Intelligent Medica Imaging, Inc.1993—
0 (this device)K003301Diffmaster Octavia Automatic Hematology AnalyzerCellaVision AB2001—
+1K033840Cellavision DM96 Automatic Hematology AnalyzerCellaVision AB20041
+2K092868Cellavision DM1200 Automated Hematology Analyzer, Model XU-10127CellaVision AB20092
+2K092116Easycell Cell LocatorMedica Corp.2010—
+3K201301X100 with Full Field Peripheral Blood Smear (PBS) ApplicationScopio Labs, Ltd.2020—
+4K220013X100HT with Slide Loader with Full Field Peripheral Blood Smear (PBS)…Scopio Labs, Ltd.2022—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200410
200810
200910
201010
201110
201710
201810
202020
202210
202310
202510
FIG. 1 — Lineage of K003301, 1993–2025Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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

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. #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? (2)

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.

TypeNumberDeviceApplicantDecidedRecalls
*K925670IMS-200
Summary page 1
…nt to the Romanowski (MGG)-Stain manual light microscopic process for cell classification and the IMI MICRO21 with WBC Diff (White blood cell Differential, 510(k) number K925670/A). Description of the Device : The DiffMaster-Octavia™ is an automated cell locating device for differential count of white bl…
Intelligent Medica Imaging, Inc.1993—
*—Romanowski (MGG)-Stain manual light microscopic process for cell classification
Named without a submission number
—

Also cleared against K925670: 4 other devices →

What descends from it? (12)

See all 12

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

NumberDeviceApplicantDecidedDescendants
K033840Cellavision DM96 Automatic Hematology AnalyzerCellaVision AB200411

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.
  • Of its descendants, K033840 (CellaVision AB, 2004) has gone furthest, with 11 descendants of its own.
  • 4 other devices also cite its predicate K925670.

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—

What is it indicated for?

The DiffMaster Octavia™ is an automated cell locating device.

DiffMaster Octavia automatically locates and presents images of blood cells on peripheral blood specimens. The operator identifies and verifies the suggested classification of each cell according to type.

DiffMaster Octavia is intended to bc used by skilled operators, trained in the use of the instrument and in recognition of leukocyte classes.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

Also cleared against K925670

4 other devices cite the same predicate.

  • K984188Automated Cellular Imaging System (Acis)Chroma Vision Medical Systems, Inc. · 1999
  • K980375Winscan Automated Imaging SystemApplied Imaging Corp. · 1998
  • K960774MICRO21 with AnaTriangle Biomedical Sciences, Inc. · 1996
  • K960776MICRO21 with ReticTriangle Biomedical Sciences, Inc. · 1996

More from CellaVision AB

7 FDA decisions under this applicant name. See the company

  • K200595CellaVision DC-1, CellaVision DC-1 PPACellaVision AB · 2020
  • K171315Advanced RBC ApplicationCellaVision AB · 2017
  • K102778Cellavision DM1200 with the Body Fluid ApplictionCellaVision AB · 2011
  • K092868Cellavision DM1200 Automated Hematology Analyzer, Model XU-10127CellaVision AB · 20092 recalls
  • K080595Cellavision DM96 with the Body Fluid ApplicationCellaVision AB · 2008

Recent decisions in JOY

The JOY category page

  • K243144X100/X100HT with Full Field Peripheral Blood Smear (PBS) ApplicationScopio Labs, Ltd. · 2025
  • K221309AI100 with ShonitSigtuple Technologies Pvt., Ltd. · 2023
  • K220013X100HT with Slide Loader with Full Field Peripheral Blood Smear (PBS) ApplicationScopio Labs, Ltd. · 2022
  • K200595CellaVision DC-1, CellaVision DC-1 PPACellaVision AB · 2020
  • K201301X100 with Full Field Peripheral Blood Smear (PBS) ApplicationScopio Labs, Ltd. · 2020

https://510kreport.com/device/K003301 · printed Nov 6, 2026

Cite this page

510(k) Report. “K003301: Diffmaster Octavia Automatic Hematology Analyzer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K003301

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Record history
  • FDA decision record loaded May 2, 2026
  • Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026