510(k) · Cleared
Recalled · Class II · 2025Alinity h-series System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Abbott Laboratories · GKZ Counter, Differential Cell
Cleared on Aug 4, 2023 as substantially equivalent to K112605 (Sysmex America, Inc., 2012) after a 576-day review. Its family tree reaches back 3 generations to 2004. 1 later device descends from it. It has been recalled 2 times.
- Decided
- Aug 4, 2023
- Review
- 576 days
- Class
- Class II
- Product code
- GKZ
- Recalls
- 2
- Predicates
- 1
Its longest line of descent runs back 3 generations to K040073 (2004). 1 later device descends 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 deviceK220031 Alinity h-series SystemAbbott Laboratories · 2023
- Descendant · cites it directly · 0 of its ownK243283 Alinity h-series SystemAbbott Laboratories · 2025 · Recalled
Most influential descendants
Showing 1 of 1 · See all- K243283Alinity h-series SystemAbbott Laboratories · 2025 · cites it directly0descendants
View 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) | K220031 | Alinity h-series System | Abbott Laboratories | 2023 | — |
| +1 | K243283 | Alinity h-series System | Abbott Laboratories | 2025 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2025 | 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 5…Page 1 of 28 IV. Predicate Device Sysmex® XN-Series (XN-10, XN-20) Automated Hematology Analyzers (K112605) V. Device Description The Alinity h-series system is a multimodule system that consists of different combinations of o… | 2012 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K243283 | Alinity h-series System | 2025 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Sep 18, 2025 | Class II | Z-0489-2026 | Software design | Software issue for hq analyzer results in system not visibly applying appropriate flagging to results when saturation is present which may result in incorrect results. |
| Jun 14, 2024 | Class II | Z-2681-2024 | Software design | 1)If Complete Blood Count with differential and reticulocyte(CBC+Diff+Retic) sample is run, then immediately following on same rack CBC+Diff sample is run, then falsely low red blood cell count may occur, generating falsely high Mean Cell… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 19 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, K243283 (Abbott Laboratories, 2025) has gone furthest, with 0 descendants 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. 2023, 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 Alinity h-series System is an integrated hematology analyzer (Alinity hq) and slide maker stainer (Alinity hs) intended for screening patient populations found in clinical laboratories by qualified health care professionals. The Alinity h-series System can be configured as: • One standalone automated hematology analyzer system. • A multimodule system that includes at least one Alinity hq analyzer module and may include one Alinity hs slide maker…
Read the full statement (186 words)
The Alinity h-series System is an integrated hematology analyzer (Alinity hq) and slide maker stainer (Alinity hs) intended for screening patient populations found in clinical laboratories by qualified health care professionals. The Alinity h-series System can be configured as:
• One standalone automated hematology analyzer system.
• A multimodule system that includes at least one Alinity hq analyzer module and may include one Alinity hs slide maker stainer module.
The Alinity hq analyzer module provides complete blood count and a 6-part white blood cell differential for normal and abnormal cells in capillary and venous whole blood collected in K2EDTA or K3EDTA. The Alinity hq analyzer provides quantitative results for the following measurands: WBC, NEU, %N, LYM, %L, MON, %M, EOS, %E, BASO, %B, IG, %IG, RBC, HCT, HGB, MCV, MCH, MCHC, MCHr, RDW, NRBC, NR/W, RETIC, %R, IRF, PLT, MPV, %rP. The Alinity hq analyzer module is indicated to identify patients with hematologic parameters within and outside of established reference ranges. The Alinity hs slide maker stainer module automates whole blood film preparation and staining and stains externally prepared whole blood smears.
For in-vitro diagnostic use.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K220031 · printed Nov 6, 2026
Cite this page
510(k) Report. “K220031: Alinity h-series System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K220031
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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