510(k) · Cleared
Recalled · 2006Pentra 120/Pentra 120 Retic Options SPS, Model Pentra 120
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Abx Diagnostics · GKZ Counter, Differential Cell
Cleared on Jul 29, 2002 as substantially equivalent to K962633 (Abx, Inc., 1996) and 5 other predicates after a 24-day review. Its family tree reaches back 3 generations to 1991. 2 later devices descend from it. It has been recalled 2 times.
- Decided
- Jul 29, 2002
- Review
- 24 days
- Class
- Class II
- Product code
- GKZ
- Recalls
- 2
- Predicates
- 6
Its longest line of descent runs back 3 generations to K912494 (1991). 14 ancestors in all, the oldest K870603 (1987). 2 later devices descend from it, 1 citing it directly.
- Root · 3 generations backK912494 Sysmex (TM) R-3000 Automated Reticulocyte AnalyzerToa Medical Electronics USA, Inc. · 1991
- 2 generations backK990311 Vega Retic Automated Hematology AnalyzerAbx Diagnostics · 1999
- 1 generation backK991839 Abx Pentra 120 Retic Automated Hematology AnalyzerAbx Diagnostics · 1999
- This deviceK022200 Pentra 120/Pentra 120 Retic Options SPS, Model Pentra 120Abx Diagnostics · 2002
- Descendant · cites it directly · 1 of its ownK050719 Abx Pentra DX 120: Option SPS EvolutionHoriba Abx · 2005 · Recalled
- Descendant · 2 generations on · 0 of its ownK151133 Pentra XLRHoriba Abx Sas · 2015
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 | K912494 | Sysmex (TM) R-3000 Automated Reticulocyte Analyzer | Toa Medical Electronics USA, Inc. | 1991 | — |
| −2 | K990311 | Vega Retic Automated Hematology Analyzer | Abx Diagnostics | 1999 | — |
| −1 | K991839 | Abx Pentra 120 Retic Automated Hematology Analyzer | Abx Diagnostics | 1999 | — |
| 0 (this device) | K022200 | Pentra 120/Pentra 120 Retic Options SPS, Model Pentra 120 | Abx Diagnostics | 2002 | — |
| +1 | K050719 | Abx Pentra DX 120: Option SPS Evolution | Horiba Abx | 2005 | 1 |
| +2 | K151133 | Pentra XLR | Horiba Abx Sas | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1987 | 2 | 0 |
| 1988 | 1 | 0 |
| 1991 | 1 | 0 |
| 1993 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 4 | 0 |
| 1997 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2015 | 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? (6)
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 |
|---|---|---|---|
| * | K962633 | Vega Hematology AnalyzerSummary page 2…- APE 332 B Substantial Equivalence: The ABX PENTFU 120 (version 4.50) is a modification to the predicate device ABX PENTRA 120 cleared to market under K962633, K9903 1 1 and K991839. The optional device SPS (Slide Preparation System) has a substantially equivalent predicate device Coult… | 1996 |
| * | K990311 | Vega Retic Automated Hematology AnalyzerSummary page 2…2 B Substantial Equivalence: The ABX PENTFU 120 (version 4.50) is a modification to the predicate device ABX PENTRA 120 cleared to market under K962633, K9903 1 1 and K991839. The optional device SPS (Slide Preparation System) has a substantially equivalent predicate device Coulter GEN-S SM… | 1999 |
| * | K991839 | Abx Pentra 120 Retic Automated Hematology AnalyzerSummary page 2…2 === Substantial Equivalence: The ABX PENTFU 120 (version 4.50) is a modification to the predicate device ABX PENTRA 120 cleared to market under K962633, K9903 1 1 and K991839. The optional device SPS (Slide Preparation System) has a substantially equivalent predicate device Coulter GEN-S SMTMIntegrated… | 1999 |
| * | K962988 | Coulter Gen-S SystemSummary page 2…839. The optional device SPS (Slide Preparation System) has a substantially equivalent predicate device Coulter GEN-S SMTMIntegrated Slide Maker cleared to market under K962988. The modification to the extension of the linearity range for white blood cells on whole blood and for platelets on the ABX PENT… | 1996 |
| * | K961439 | Abbott Cell-Dyn 4000 SystemSummary page 2…n to the extension of the linearity range for white blood cells on whole blood and for platelets on the ABX PENTFU 120 used two predicate devices: ABBOTT CD 4000 (K961439) : for the leukocyte extension to linearity BAKER 91 I O Plus (K953598) : for the platelet count extension to li-nearity… | 1996 |
| * | K953598 | Series 9100 Plus Automated Differential Hematology AnalyzersSummary page 2…and for platelets on the ABX PENTFU 120 used two predicate devices: ABBOTT CD 4000 (K961439) : for the leukocyte extension to linearity BAKER 91 I O Plus (K953598) : for the platelet count extension to li-nearity Description: The PENTA 120 / P 120 RETIC Automated Hematology Analyzer is a… | 1996 |
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 |
|---|---|---|---|
| K050719 | Abx Pentra DX 120: Option SPS Evolution | 2005 | 1 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Mar 24, 2006 | Not classified | Z-1334-06 | Other | Labels can be incorrectly placed on a sample tube resulting in a possible error in results attributed to a sample. |
| Jun 24, 2004 | Not classified | Z-1342-04 | Other | Power failure having impact on software. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 11 years and passes through 2 companies; a new generation was cleared every 3.0 years on median.
- 3 of the 14 ancestors have a recall of any class.
- Of its descendants, K050719 (Horiba Abx, 2005) has gone furthest, with 1 descendant of its own.
- 3 other devices also cite its predicate K962633.
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 ABX PENTRA 120 Hematology Analyzer is an automated hematology analyzer providing complete bfood count (CBC) and differential leucocyte count (DIFF) for the in vitro diagnostic use in clinical laboratories. The ABX PENTRA 120 RETIC Hematology Analyzer is an automated hematology analyzer providing complete blood count (CBC), differential leucocyte count (DIFF) as well as reticuiocyte count (RET) for the in vitro diagnostic use in clinical laboratories.…
Read the full statement (110 words)
The ABX PENTRA 120 Hematology Analyzer is an automated hematology analyzer providing complete bfood count (CBC) and differential leucocyte count (DIFF) for the in vitro diagnostic use in clinical laboratories.
The ABX PENTRA 120 RETIC Hematology Analyzer is an automated hematology analyzer providing complete blood count (CBC), differential leucocyte count (DIFF) as well as reticuiocyte count (RET) for the in vitro diagnostic use in clinical laboratories. The clinical use in the ABX PENTRA 120 RETIC Hematology Analyzer of the reticulocyte count, specifically the immature reticulocyte fi-action (IRF), is to monitor erythropoietic activity in patients.
The option of the SPS (Slide Preparation System) smears and stains on a clean microscope slide.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K022200 · printed Nov 6, 2026
Cite this page
510(k) Report. “K022200: Pentra 120/Pentra 120 Retic Options SPS, Model Pentra 120.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K022200
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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