510(k) · Cleared
ClearedHemoScreen Hematology Analyzer
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Pixcell Medical Technologies, Ltd. · GKZ Counter, Differential Cell
Cleared on Oct 29, 2018 as substantially equivalent to K112605 (Sysmex America, Inc., 2012) after a 300-day review. Its family tree reaches back 3 generations to 2004. 2 later devices descend from it.
- Decided
- Oct 29, 2018
- Review
- 300 days
- Class
- Class II
- Product code
- GKZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K040073 (2004). 2 later devices descend from it, 1 citing it directly.
- Root · 3 generations backK040073 Sysmex Automated Hematology Analyzer, XE-2100 Series (XE-2100…Sysmex America, Inc. · 2004
- 2 generations backK071967 Sysmex XE-5000Sysmex America, Inc. · 2007 · Recalled
- 1 generation backK112605 Sysmex XN-SeriesSysmex America, Inc. · 2012 · Recalled
- This deviceK180020 HemoScreen Hematology AnalyzerPixcell Medical Technologies, Ltd. · 2018
- Descendant · cites it directly · 1 of its ownK222148 HemoScreen Hematology AnalyzerPixcell Medical Technologies, Ltd. · 2023
- Descendant · 2 generations on · 0 of its ownK240636 HemoScreen Hematology AnalyzerPixcell Medical Technologies · 2024
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K040073 | Sysmex Automated Hematology Analyzer, XE-2100 Series (XE-2100, XE-2100L) | Sysmex America, Inc. | 2004 | — |
| −2 | K071967 | Sysmex XE-5000 | Sysmex America, Inc. | 2007 | 1 |
| −1 | K112605 | Sysmex XN-Series | Sysmex America, Inc. | 2012 | 2 |
| 0 (this device) | K180020 | HemoScreen Hematology Analyzer | Pixcell Medical Technologies, Ltd. | 2018 | — |
| +1 | K222148 | HemoScreen Hematology Analyzer | Pixcell Medical Technologies, Ltd. | 2023 | — |
| +2 | K240636 | HemoScreen Hematology Analyzer | Pixcell Medical Technologies | 2024 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 1 | 0 |
| 2024 | 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 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 |
|---|---|---|---|
| * | K112605 | Sysmex XN-SeriesSummary page 4…ication: 21 CFR 864.5220 807.92 (a)(3): Identification of the legally marketed predicate devices Sysmex XN Series (Sysmex America, Inc, Lincolnshire, IL), cleared under K112605 807.92 (a)(4): Device Description HemoScreen is a point of care (POC), automated hematology analyzer that provides 20 common CBC… | 2012 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K222148 | HemoScreen Hematology Analyzer | 2023 | 1 |
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 14 years and passes through 2 companies; a new generation was cleared every 4.9 years on median.
- 2 of the 3 ancestors have a recall of any class.
- Of its descendants, K222148 (Pixcell Medical Technologies, Ltd., 2023) has gone furthest, with 1 descendant of its own.
- 12 other devices also cite its predicate K112605.
How does its category compare?
All GKZ devicesGKZ Counter, Differential Cell: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, this device’s year, is highlighted.
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 HemoScreen is a point-of-care (POC) automated hematology analyzer intended for the enumeration and classification of the following parameters in capillary and venous whole blood (K2EDTA anticoagulated): WBC, RBC, HGB, HCT, MCV, MCH, MCHC, RDW, PLT, MPV, NEUT%, NEUT#, LYMP%, LYMP#, MONO%, MONO#, EO%, EO#, BASO %, and BASO#. The HemoScreen is for in vitro diagnostic use in clinical laboratories and/or POC settings for adults and children at least 2 years of age.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K180020 · printed Nov 6, 2026
Cite this page
510(k) Report. “K180020: HemoScreen 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/K180020
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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