510(k) · Cleared
ClearedCELL-DYN Emerald 22 AL 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 Mar 15, 2019 as substantially equivalent to K110381 (Abbott Laboratories, 2011) after a 32-day review. Its family tree reaches back 3 generations to 1997.
- Decided
- Mar 15, 2019
- Review
- 32 days
- Class
- Class II
- Product code
- GKZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K971152 (1997). No later device cites it as a predicate yet.
- Root · 3 generations backK971152 Abbott Cell-Dyn 4000 Immature Reticulocyte Fraction (Irf)Abbott Laboratories · 1997 · Recalled
- 2 generations backK991605 Cell-Dyn 3500 System with Immature Reticulocyte Fraction (Irf)…Abbott Laboratories · 1999 · Recalled
- 1 generation backK110381 Cell-Dyn Emerald 22 SystemAbbott Laboratories · 2011
- This deviceK190294 CELL-DYN Emerald 22 AL SystemAbbott Laboratories · 2019
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K971152 | Abbott Cell-Dyn 4000 Immature Reticulocyte Fraction (Irf) | Abbott Laboratories | 1997 | 1 |
| −2 | K991605 | Cell-Dyn 3500 System with Immature Reticulocyte Fraction (Irf), Cell-Dyn 3700… | Abbott Laboratories | 1999 | 9 |
| −1 | K110381 | Cell-Dyn Emerald 22 System | Abbott Laboratories | 2011 | — |
| 0 (this device) | K190294 | CELL-DYN Emerald 22 AL System | Abbott Laboratories | 2019 | — |
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 |
|---|---|---|---|
| * | K110381 | Cell-Dyn Emerald 22 SystemSummary page 4…Trade Marks: CELL-DYN Emerald is a trademark of Abbott Laboratories 0B III 1B Predicate Device The predicate device is CELL-DYN Emerald 22 system, K110381, and 510(k) cleared December 22, 2011. number… | 2011 |
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 22 years and passes through 1 company; a new generation was cleared every 7.2 years on median.
- 2 of the 3 ancestors have a recall of any class.
How does its category compare?
All GKZ devicesGKZ Counter, Differential Cell: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, 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 CELL-DYN Emerald 22 AL System is a quantitative multi-parameter automated hematology analyzer designed for in-vitro diagnostic use in clinical laboratories for enumeration of the following parameters: WBC, LYM%, LYM #, MON %, MON #, NEU%, NEU #, EOS%, EOS #, BAS%, BAS #, RBC, HCT, MCV, RDW, HGB, MCH, MCHC, PLT, MPV in K2EDTA anti-coagulated whole blood.
The CELL-DYN Emerald 22 AL is indicated for use to identify patients with hematologic parameters within and outside of established reference ranges.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K190294 · printed Nov 6, 2026
Cite this page
510(k) Report. “K190294: CELL-DYN Emerald 22 AL System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K190294
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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