510(k) Report

510(k) · Cleared

Recalled · 2006

Abx Pentra DX 120: Option SPS Evolution

K050719510(k) TraditionalCleared Apr 26, 200536-day reviewClass II21 CFR 864.5220Recalls 1

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Horiba Abx · GKZ Counter, Differential Cell

Cleared on Apr 26, 2005 as substantially equivalent to K962633 (Abx, Inc., 1996) and 5 other predicates after a 36-day review. Its family tree reaches back 4 generations to 1991. 1 later device descends from it. It has been recalled once.

Decided
Apr 26, 2005
Review
36 days
Class
Class II
Product code
GKZ
Recalls
1
Predicates
6

Its longest line of descent runs back 4 generations to K912494 (1991). 19 ancestors in all, the oldest K870603 (1987). 1 later device descends from it, 1 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 1999: 1 other ancestor1996: 4 other ancestors1997: 2 other ancestors1995: 2 other ancestors1987: 2 other ancestors1994: 1 other ancestor1993: 1 other ancestor1991: 1 other ancestor1988: 1 other ancestor2015: 1 descendant clearedK912494 · Sysmex (TM) R-3000 Automated Reticulocyte Analyzer · Toa Medical Electronics USA, Inc. · 1991×2: 2 generations cleared close together, K990311 (1999), K991839 (1999) K022200 · Pentra 120/Pentra 120 Retic Options SPS, Model Pentra 120 · Abx Diagnostics · 2002 · recalled1990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 3 other ancestors2 generations back: 7 other ancestors3 generations back: 5 other ancestors 1 generation forward: 1 descendant K022200 · Pentra 120/Pentra 120 Retic Options SPS, Model Pentra 120 · Abx Diagnostics · 2002 · recalledK991839 · Abx Pentra 120 Retic Automated Hematology Analyzer · Abx Diagnostics · 1999K990311 · Vega Retic Automated Hematology Analyzer · Abx Diagnostics · 1999K912494 · Sysmex (TM) R-3000 Automated Reticulocyte Analyzer · Toa Medical Electronics USA, Inc. · 19910
  1. Root · 4 generations backK912494 Sysmex (TM) R-3000 Automated Reticulocyte AnalyzerToa Medical Electronics USA, Inc. · 1991
  2. 3 generations backK990311 Vega Retic Automated Hematology AnalyzerAbx Diagnostics · 1999
  3. 2 generations backK991839 Abx Pentra 120 Retic Automated Hematology AnalyzerAbx Diagnostics · 1999
  4. 1 generation backK022200 Pentra 120/Pentra 120 Retic Options SPS, Model Pentra 120Abx Diagnostics · 2002 · Recalled
  5. This deviceK050719 Abx Pentra DX 120: Option SPS EvolutionHoriba Abx · 2005
  6. Descendant · cites it directly · 0 of its ownK151133 Pentra XLRHoriba Abx Sas · 2015

Most influential descendants

Showing 1 of 1 · See all
  • K151133Pentra XLRHoriba Abx Sas · 2015 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−4K912494Sysmex (TM) R-3000 Automated Reticulocyte AnalyzerToa Medical Electronics USA, Inc.1991—
−3K990311Vega Retic Automated Hematology AnalyzerAbx Diagnostics1999—
−2K991839Abx Pentra 120 Retic Automated Hematology AnalyzerAbx Diagnostics1999—
−1K022200Pentra 120/Pentra 120 Retic Options SPS, Model Pentra 120Abx Diagnostics20022
0 (this device)K050719Abx Pentra DX 120: Option SPS EvolutionHoriba Abx2005—
+1K151133Pentra XLRHoriba Abx Sas2015—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198720
198810
199110
199310
199410
199520
199640
199720
199910

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201510
FIG. 1 — Lineage of K050719, 1991–2015Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K250943 Sysmex XR-Series (XR-10) Automated Hematology…score 13.2 · 3 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against? (7)

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.

TypeNumberDeviceApplicantDecidedRecalls
*K962633Vega Hematology Analyzer
Summary page 2
…Section 6-1 Substantial Equivalence: The ABX PENTRA DX 120 is considered comparable to the predicate device ABX PENTRA, 120 cleared to market under K962633, K99031 1, K991839 and K022200. The fundamental scientific technology for the analyzer itself has not changed. Including, hemato…
Abx, Inc.1996—
*K990311Vega Retic Automated Hematology Analyzer
Summary page 2
…ion 6-1 Substantial Equivalence: The ABX PENTRA DX 120 is considered comparable to the predicate device ABX PENTRA, 120 cleared to market under K962633, K99031 1, K991839 and K022200. The fundamental scientific technology for the analyzer itself has not changed. Including, hematological pa…
Abx Diagnostics1999—
*K991839Abx Pentra 120 Retic Automated Hematology Analyzer
Summary page 2
…== Page 2 === Substantial Equivalence: The ABX PENTRA DX 120 is considered comparable to the predicate device ABX PENTRA, 120 cleared to market under K962633, K99031 1, K991839 and K022200. The fundamental scientific technology for the analyzer itself has not changed. Including, hematological parameters…
Abx Diagnostics1999—
*K022200Pentra 120/Pentra 120 Retic Options SPS, Model Pentra 120
Summary page 2
…= Substantial Equivalence: The ABX PENTRA DX 120 is considered comparable to the predicate device ABX PENTRA, 120 cleared to market under K962633, K99031 1, K991839 and K022200. The fundamental scientific technology for the analyzer itself has not changed. Including, hematological parameters for complete…
Abx Diagnostics20022
*K961439Abbott Cell-Dyn 4000 System
Summary page 2
…NRBC parameter on the ABX PENTRA DX 120 the following different predicate devices were used during the clinical evaluation of the NRBC parameter: ABBOT[ CD 4000 (K961439) SYSMEX XE-2100 (K992875) Description: The PENTRA DX 120 Automated Hematology Analyzer is a bench-top, clinical labora…
Abbott Diagnostics19967
*K992875Sysmex XE-2100, Automatated Hematology Analyzer
Summary page 2
…DX 120 the following different predicate devices were used during the clinical evaluation of the NRBC parameter: ABBOT[ CD 4000 (K961439) SYSMEX XE-2100 (K992875) Description: The PENTRA DX 120 Automated Hematology Analyzer is a bench-top, clinical laboratory instrument which analyzes in…
Sysmex Corp.19991
*—SPS used on the ABX PENTRA 120
Named without a submission number
—

Also cleared against K962633: 3 other devices →

What descends from it? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K151133Pentra XLRHoriba Abx Sas20150

Has anything in its family been recalled? (0 Class I)

Recalls of this device

DateClassRecallRoot causeReason
Mar 24, 2006Not classifiedZ-1334-06OtherLabels can be incorrectly placed on a sample tube resulting in a possible error in results attributed to a sample.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • The line of descent spans 14 years and passes through 3 companies; a new generation was cleared every 3.0 years on median.
  • 5 of the 19 ancestors have a recall of any class.
  • Of its descendants, K151133 (Horiba Abx Sas, 2015) has gone furthest, with 0 descendants of its own.
  • 3 other devices also cite its predicate K962633.

How does its category compare?

All GKZ devices

GKZ Counter, Differential Cell: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · GKZ

4in 2025

2007: 62008: 62009: 62010: 42011: 32012: 32013: 12014: 32015: 32016: 32017: 42018: 32019: 52020: 12022: 32023: 42024: 32025: 42026 (partial year): 4
2007high 6 (2007) · low 0 (2021)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · GKZ

108in 2025

2007: 117 days median2008: 99 days median2009: 147 days median2010: 290 days median2011: 315 days median2012: 408 days median2014: 165 days median2015: 273 days median2016: 198 days median2017: 280 days median2018: 270 days median2019: 210 days median2022: 638 days median2023: 329 days median2024: 157 days median2025: 108 days median2026 (partial year): 254 days median
2007high 638 (2022) · low 99 (2008)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · GKZ

1in 2025

2007: 372008: 52009: 132010: 272011: 282012: 72013: 62015: 32016: 32017: 32018: 2, 2 Class I2019: 22020: 12022: 42023: 12025: 1
2007high 37 (2007) · low 0 (2014)2026

Class I (2 since 2007) Class II/III not classified

Adverse event reports per year · GKZ

77in 2025

2007: 2682008: 9252009: 5592010: 8962011: 2,9052012: 2,9592013: 3,0702014: 3,1122015: 1,9722016: 3,3382017: 2292018: 4972019: 9082020: 3422021: 3912022: 1982023: 1552024: 1152025: 77
2007high 3,338 (2016) · low 77 (2025)2025

MAUDE reports naming product code GKZ, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
2007611737268
20086995925
2009614713559
2010429027896
20113315282,905
2012340872,959
20131—63,070
2014316503,112
2015327331,972
2016319833,338
201742803229
201832702 (2)497
201952102908
20201—1342
20210—0391
202236384198
202343291155
202431570115
20254108177
202642540—

What is it indicated for?

The ABX PENTRA DX 120 Hematology Analyzer is an automated hematology analyzer providing complete blood count (CBC), differential leucocyte count (DIFF) as well as reticulocyte count (RET), and nucleated red blood cell count (NRBC) for the in vitro diagnostic use in clinical laboratories.

The clinical use of the reticulocyte count, specifically the immature reticulocyte fraction (IRF), is to monitor erythropoietic activity in patients.

The option of the SPS Evolution (Slide Preparation System) smears and stains on a clean microscope slide.

Indications for use as stated in the FDA summary.

Also cleared against K962633

3 other devices cite the same predicate.

  • K022200Pentra 120/Pentra 120 Retic Options SPS, Model Pentra 120Abx Diagnostics · 20022 recalls
  • K992511Abx Pentra 60 Hematology AnalyzerAbx Diagnostics · 19991 recall
  • K990311Vega Retic Automated Hematology AnalyzerAbx Diagnostics · 1999

More from Horiba Abx

19 FDA decisions under this applicant name. See the company

  • K073309Abx Pentra HBA1C WB, Calibrator, Control and Hemolysis ReagentHoriba Abx · 2008
  • K081276Abx Pentra Glucose HK CP, Abx Pentra Uric Acid CP, Abx Pentra Urine Control L/HHoriba Abx · 20081 recall
  • K071779Abx Pentra Urine CalHoriba Abx · 2008
  • K072115Abx Pentra Creatinine 120 CP, Total Protein 100 CP, Multical, N and P Controls, and Urine Control L/HHoriba Abx · 20071 recall
  • K070146Abx Pentra Glucose HK CP, Urea CP, Uric Acid CPHoriba Abx · 2007

Recent decisions in GKZ

The GKZ category page

  • K260781Yumizen H550Horiba Abx Sas · 2026
  • K253212XR-Series (XR-10, XR-20) Automated Hematology AnalyzersSysmex America, Inc. · 2026
  • K243348Athelas HomeAthelas, Inc. · 2026
  • K251249Tru Hematology TestTruvian Sciences, Inc. · 2026
  • K250943Sysmex XR-Series (XR-10) Automated Hematology AnalyzerSysmex America, Inc. · 2025

https://510kreport.com/device/K050719 · printed Nov 4, 2026

Cite this page

510(k) Report. “K050719: Abx Pentra DX 120: Option SPS Evolution.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K050719

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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