510(k) · Cleared
ClearedMascot MD Hematology Analyzer/ Model MD 700
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cdc Technologies, Inc. · GKZ Counter, Differential Cell
Cleared on Nov 3, 1998 as substantially equivalent to K981568 (Cdc Technologies, Inc., 1998) after a 21-day review. Its family tree reaches back 2 generations to 1988.
- Decided
- Nov 3, 1998
- Review
- 21 days
- Class
- Class II
- Product code
- GKZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K885093 (1988). No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
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 K250943 Sysmex XR-Series (XR-10) Automated Hematology…score 13.2 · 3 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 |
|---|---|---|---|
| * | K981568 | Mascot MD Hematology Analyzer, Model MD 800Summary page 1…ally marketed device to which the submitter claims substantial equivalence. MASCOT MD Hematology Analyzer Model MD 800 Manufactured by CDC Technologies, Inc. 510(k) No. K981568 Description of the MD 700 Description: In General. The MD 700 is a quantitative analyzer of peripheral human blood for in vitro… | 1998 |
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?
- The line of descent spans 10 years and passes through 2 companies; a new generation was cleared every 9.6 years on median.
- None of the 2 ancestors has a recall.
How does its category compare?
All GKZ devicesGKZ Counter, Differential Cell: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · GKZ
4in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · GKZ
108in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GKZ
1in 2025
Class I (2 since 2007) Class II/III not classified
Adverse event reports per year · GKZ
77in 2025
MAUDE reports naming product code GKZ, 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 | 6 | 117 | 37 | 268 |
| 2008 | 6 | 99 | 5 | 925 |
| 2009 | 6 | 147 | 13 | 559 |
| 2010 | 4 | 290 | 27 | 896 |
| 2011 | 3 | 315 | 28 | 2,905 |
| 2012 | 3 | 408 | 7 | 2,959 |
| 2013 | 1 | — | 6 | 3,070 |
| 2014 | 3 | 165 | 0 | 3,112 |
| 2015 | 3 | 273 | 3 | 1,972 |
| 2016 | 3 | 198 | 3 | 3,338 |
| 2017 | 4 | 280 | 3 | 229 |
| 2018 | 3 | 270 | 2 (2) | 497 |
| 2019 | 5 | 210 | 2 | 908 |
| 2020 | 1 | — | 1 | 342 |
| 2021 | 0 | — | 0 | 391 |
| 2022 | 3 | 638 | 4 | 198 |
| 2023 | 4 | 329 | 1 | 155 |
| 2024 | 3 | 157 | 0 | 115 |
| 2025 | 4 | 108 | 1 | 77 |
| 2026 | 4 | 254 | 0 | — |
What is it indicated for?
The MD 700 is a multi-parameter, automated hematology analyzer used to perform in vitro analysis of human peripheral blood in clinical laboratories. The MD 700 reports on the following parameters: White Blood Cells (Leukocytes) wBC Red Blood Cells (Erythrocytes) RBC Hemoglobin Concentration Hgb Hematocrit (relative volume of erythrocytes) Hct Mean Corpuscular (erythrocyte) Volume MCV Mean Corpuscular (erythrocyte) Hemoglobin MCH Mean Corpuscular…
Read the full statement (102 words)
The MD 700 is a multi-parameter, automated hematology analyzer used to perform in vitro analysis of human peripheral blood in clinical laboratories.
The MD 700 reports on the following parameters:
White Blood Cells (Leukocytes) wBC
Red Blood Cells (Erythrocytes) RBC
Hemoglobin Concentration Hgb
Hematocrit (relative volume of erythrocytes) Hct
Mean Corpuscular (erythrocyte) Volume MCV
Mean Corpuscular (erythrocyte) Hemoglobin MCH
Mean Corpuscular (erythrocyte) Hemoglobin Concentration MCHC
Red Blood Cell (erythrocyte volume) Distribution Width RDW
Platelet or Thrombocyte Count PIt
Granulocyte (number) GR#
Granulocyte (percent of WBC) GR%
Lymphocyte (number) LY#
Lymphocyte (percent of WBC) LY%
Monocyte (number) MO#
Monacyte (percent of WBC) MO%
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/K983562 · printed Nov 4, 2026
Cite this page
510(k) Report. “K983562: Mascot MD Hematology Analyzer/ Model MD 700.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K983562
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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