510(k) Report

510(k) · Cleared

Cleared

Mascot MD Hematology Analyzer, Model MD 800

K981568510(k) TraditionalCleared Aug 21, 1998112-day reviewClass II21 CFR 864.5220

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

Cdc Technologies, Inc. · GKZ Counter, Differential Cell

Cleared on Aug 21, 1998 as substantially equivalent to K885093 (Coulter Electronics, Inc., 1988) after a 112-day review. Its family tree reaches back 1 generation to 1988. 1 later device descends from it.

Decided
Aug 21, 1998
Review
112 days
Class
Class II
Product code
GKZ
Recalls
None
Predicates
1

Its longest line of descent runs back 1 generation to K885093 (1988). 1 later device descends from it, 1 citing it directly.

Descendants, by year cleared 1998: 1 descendant clearedK885093 · Coulter STKS · Coulter Electronics, Inc. · 19881990200020102020
Descendants, by generation 1 generation forward: 1 descendant K885093 · Coulter STKS · Coulter Electronics, Inc. · 19880
  1. Root · 1 generation backK885093 Coulter STKSCoulter Electronics, Inc. · 1988
  2. This deviceK981568 Mascot MD Hematology Analyzer, Model MD 800Cdc Technologies, Inc. · 1998
  3. Descendant · cites it directly · 0 of its ownK983562 Mascot MD Hematology Analyzer/ Model MD 700Cdc Technologies, Inc. · 1998

Most influential descendants

Showing 1 of 1 · See all
  • K983562Mascot MD Hematology Analyzer/ Model MD 700Cdc Technologies, Inc. · 1998 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K885093Coulter STKSCoulter Electronics, Inc.1988—
0 (this device)K981568Mascot MD Hematology Analyzer, Model MD 800Cdc Technologies, Inc.1998—
+1K983562Mascot MD Hematology Analyzer/ Model MD 700Cdc Technologies, Inc.1998—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199810
FIG. 1 — Lineage of K981568, 1988–1998Source: 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 GKZ? 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 GKZ device

  1. #1 K250943 Sysmex XR-Series (XR-10) Automated Hematology…score 13.2 · 3 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? (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.

TypeNumberDeviceApplicantDecidedRecalls
*K885093Coulter STKS
Summary page 1
…tification of the legally marketed device to which the submitter claims substantial equivalence. Coulter Model STKS Manufactured by Coulter Electronics, Inc. 501(k) No. K885093 Description of the MD 800 Description: In General. The MD 800 is a quantitative analyzer of peripheralhuman blood for in vitro d…
Coulter Electronics, Inc.1988—

Also cleared against K885093: 3 other devices →

What descends from it? (1)

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

NumberDeviceApplicantDecidedDescendants
K983562Mascot MD Hematology Analyzer/ Model MD 700Cdc Technologies, Inc.19980

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, K983562 (Cdc Technologies, Inc., 1998) has gone furthest, with 0 descendants of its own.
  • 3 other devices also cite its predicate K885093.

How does its category compare?

All GKZ devices

GKZ Counter, Differential Cell: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · GKZ

4in 2025

2007: 62008: 62009: 62010: 42011: 32012: 32013: 12014: 32015: 32016: 32017: 42018: 32019: 52020: 12022: 32023: 42024: 32025: 42026 (partial year): 4
2007high 6 (2007) · low 0 (2021)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · GKZ

108in 2025

2007: 117 days median2008: 99 days median2009: 147 days median2010: 290 days median2011: 315 days median2012: 408 days median2014: 165 days median2015: 273 days median2016: 198 days median2017: 280 days median2018: 270 days median2019: 210 days median2022: 638 days median2023: 329 days median2024: 157 days median2025: 108 days median2026 (partial year): 254 days median
2007high 638 (2022) · low 99 (2008)2026

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

Recalls per year · GKZ

1in 2025

2007: 372008: 52009: 132010: 272011: 282012: 72013: 62015: 32016: 32017: 32018: 2, 2 Class I2019: 22020: 12022: 42023: 12025: 1
2007high 37 (2007) · low 0 (2014)2026

Class I (2 since 2007) Class II/III not classified

Adverse event reports per year · GKZ

77in 2025

2007: 2682008: 9252009: 5592010: 8962011: 2,9052012: 2,9592013: 3,0702014: 3,1122015: 1,9722016: 3,3382017: 2292018: 4972019: 9082020: 3422021: 3912022: 1982023: 1552024: 1152025: 77
2007high 3,338 (2016) · low 77 (2025)2025

MAUDE reports naming product code GKZ, 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
2007611737268
20086995925
2009614713559
2010429027896
20113315282,905
2012340872,959
20131—63,070
2014316503,112
2015327331,972
2016319833,338
201742803229
201832702 (2)497
201952102908
20201—1342
20210—0391
202236384198
202343291155
202431570115
20254108177
202642540—

What is it indicated for?

The MD 800 is a multi-parameter, automated hematology analyzer used to perform in vitro diagnosis of peripheral human blood in clinical laboratories. The MD 800 reports on the following parameters: White Blood Cells (Leukocytes) WBC Red Blood Cells (Erythrocytes) RBC Hemoglobin Concentration Hgb Hematocrit (relative volume of erythrocytes) Het Mean Corpuscular (erythrocyte) Volume MCV Mean Corpuscular (erythrocyte) Hemoglobin MCH Mean Corpuscular…

Read the full statement (115 words)

The MD 800 is a multi-parameter, automated hematology analyzer used to perform in vitro diagnosis of peripheral human blood in clinical laboratories.

The MD 800 reports on the following parameters:

White Blood Cells (Leukocytes) WBC

Red Blood Cells (Erythrocytes) RBC

Hemoglobin Concentration Hgb

Hematocrit (relative volume of erythrocytes) Het

Mean Corpuscular (erythrocyte) Volume MCV

Mean Corpuscular (erythrocyte) Hemoglobin MCH

Mean Corpuscular (erythrocyte) Hemogilobin Concentration MCHC

Red Blood Cell {(erythrocyte volume) Distribution Width RDW

Platelet or Thrombocyte Count Pit

Mean Platelet (thrombocyte) Volume MPV

Lymphocyte (number) LY#

Lymphocyte (percent of WBC) LY%

Monocyte (number) MO#

Monocyte (percent of WBC) MO%

Neutrophil (number) NE#

Neutrophil (percent of WBC) NE%

Eosinophil (number) EO#

Eosinophil (percent of WBC) EO%

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 K885093

3 other devices cite the same predicate.

  • K991070Coulter Z2 AnalyzerCoulter Corp. · 1999
  • K962988Coulter Gen-S SystemCoulter Corp. · 19964 recalls
  • K961278Coulter STKS Analyzer with CD4 & CD8 Lymphocyte AnalysisCoulter Corp. · 1996

More from Cdc Technologies, Inc.

2 FDA decisions under this applicant name. See the company

  • K983562Mascot MD Hematology Analyzer/ Model MD 700Cdc Technologies, Inc. · 1998

Recent decisions in GKZ

The GKZ category page

  • K260781Yumizen H550Horiba Abx Sas · 2026
  • K253212XR-Series (XR-10, XR-20) Automated Hematology AnalyzersSysmex America, Inc. · 2026
  • K243348Athelas HomeAthelas, Inc. · 2026
  • K251249Tru Hematology TestTruvian Sciences, Inc. · 2026
  • K250943Sysmex XR-Series (XR-10) Automated Hematology AnalyzerSysmex America, Inc. · 2025

https://510kreport.com/device/K981568 · printed Nov 4, 2026

Cite this page

510(k) Report. “K981568: Mascot MD Hematology Analyzer, Model MD 800.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K981568

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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