510(k) · Cleared
Recalled · 2006Excell 22
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Mwi, Inc. · GKZ Counter, Differential Cell
Cleared on Jul 1, 1999 as substantially equivalent to K890491 (Abbott Diagnostics, 1989) and 1 other predicate after a 59-day review. Its family tree reaches back 1 generation to 1989. 1 later device descends from it. It has been recalled 4 times.
- Decided
- Jul 1, 1999
- Review
- 59 days
- Class
- Class II
- Product code
- GKZ
- Recalls
- 4
- Predicates
- 2
Its longest line of descent runs back 1 generation to K890491 (1989). 2 ancestors in all. 1 later device descends from it, 1 citing it directly.
Most influential descendants
Showing 1 of 1 · See all- K072869Pointcare Now SystemPointcare Technologies, Inc. · 2008 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K890491 | Cell-Dyn 3000 Multi-Parameter Hematology Analyer | Abbott Diagnostics | 1989 | 1 |
| 0 (this device) | K991539 | Excell 22 | Mwi, Inc. | 1999 | — |
| +1 | K072869 | Pointcare Now System | Pointcare Technologies, Inc. | 2008 | 1 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 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? (3)
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 |
|---|---|---|---|
| * | K890491 | Cell-Dyn 3000 Multi-Parameter Hematology AnalyerSummary page 2…== Page 2 === The predicate devices are marketed under 510(k) clearance. The Cell-Dyn 3000 is manufactured by Sequoia Turmer Corporation, (now Abbott Laboratories) under K890491. The DATACELL 18MS is manufactured by MW], Inc. d.b.a. Danam Electronics under K945678. DEVICE DESCRIPTION The EXCELL 22is a DA… | 1989 |
| * | K945678 | Datacell 18MSSummary page 2…000 is manufactured by Sequoia Turmer Corporation, (now Abbott Laboratories) under K890491. The DATACELL 18MS is manufactured by MW], Inc. d.b.a. Danam Electronics under K945678. DEVICE DESCRIPTION The EXCELL 22is a DATACELL 18MS with an additional optical channel for performing a five-part white cell di… | 1995 |
| * | — | Coulter S+IV Named without a submission number |
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 |
|---|---|---|---|
| K072869 | Pointcare Now System | 2008 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Sep 20, 2006 | Not classified | Z-0450-2007 | Other | System has given inaccurate readings when running samples that trigger an extra rinse due to very high WBC, RBC or Platlet counts. |
| Sep 20, 2006 | Not classified | Z-0451-2007 | Other | System has given inaccurate readings when running samples that trigger an extra rinse due to very high WBC, RBC or Platlet counts. |
| Aug 24, 2006 | Not classified | Z-0448-2007 | Other | Flags and alerts on the user interface will not automatically transfering to the LIS. |
| Aug 24, 2006 | Not classified | Z-0449-2007 | Other | Flags and alerts on the user interface will not automatically transfering to the LIS. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
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 EXCELL™ 22, is an in-vitro diagnostic instrument for use in counting blood cells, classifying white blood cells (WBC) and flagging specimens containing abnormal blood cells in clinical laboratories at diverse sites. Per NCCLS H20A section 4(9), flagging is defined as “identifying a sample or blood film for further attention or review”.
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/K991539 · printed Nov 6, 2026
Cite this page
510(k) Report. “K991539: Excell 22.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K991539
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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