510(k) · Cleared
ClearedPentra XLR
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Horiba Abx Sas · GKZ Counter, Differential Cell
Cleared on Dec 9, 2015 as substantially equivalent to K024002 (Abx Diagnostics, 2003) and 3 other predicates after a 225-day review. Its family tree reaches back 5 generations to 1991.
- Decided
- Dec 9, 2015
- Review
- 225 days
- Class
- Class II
- Product code
- GKZ
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 5 generations to K912494 (1991). 22 ancestors in all, the oldest K870603 (1987). No later device cites it as a predicate yet.
- Root · 5 generations backK912494 Sysmex (TM) R-3000 Automated Reticulocyte AnalyzerToa Medical Electronics USA, Inc. · 1991
- 4 generations backK990311 Vega Retic Automated Hematology AnalyzerAbx Diagnostics · 1999
- 3 generations backK991839 Abx Pentra 120 Retic Automated Hematology AnalyzerAbx Diagnostics · 1999
- 2 generations backK022200 Pentra 120/Pentra 120 Retic Options SPS, Model Pentra 120Abx Diagnostics · 2002 · Recalled
- 1 generation backK050719 Abx Pentra DX 120: Option SPS EvolutionHoriba Abx · 2005 · Recalled
- This deviceK151133 Pentra XLRHoriba Abx Sas · 2015
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K912494 | Sysmex (TM) R-3000 Automated Reticulocyte Analyzer | Toa Medical Electronics USA, Inc. | 1991 | — |
| −4 | K990311 | Vega Retic Automated Hematology Analyzer | Abx Diagnostics | 1999 | — |
| −3 | K991839 | Abx Pentra 120 Retic Automated Hematology Analyzer | Abx Diagnostics | 1999 | — |
| −2 | K022200 | Pentra 120/Pentra 120 Retic Options SPS, Model Pentra 120 | Abx Diagnostics | 2002 | 2 |
| −1 | K050719 | Abx Pentra DX 120: Option SPS Evolution | Horiba Abx | 2005 | 1 |
| 0 (this device) | 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 |
| 1994 | 1 | 0 |
| 1995 | 2 | 0 |
| 1996 | 4 | 0 |
| 1997 | 2 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2003 | 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? (4)
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 |
|---|---|---|---|
| * | K024002 | Pentra 80Summary page 4…duct Code: GKZ Class: II 4.0 System description : 4.1 Device Description The PENTRA XLR is a device modification to the ABX PENTRA 80 (k024002), which consists in the addition of the measurement of Reticulocytes (RET) parameters to the existing Complete Blood Count (CBC)… | 2003 |
| * | K050719 | Abx Pentra DX 120: Option SPS EvolutionSummary page 10…510(k) numbers PENTRA XLR ABX PENTRA DX 120 HORIBA ABX SAS K050719 K991839… | 2005 |
| * | K991839 | Abx Pentra 120 Retic Automated Hematology AnalyzerSummary page 10…numbers PENTRA XLR ABX PENTRA DX 120 HORIBA ABX SAS K050719 K991839 K990311 7.2 Comparison with predicate Device… | 1999 |
| * | K990311 | Vega Retic Automated Hematology AnalyzerSummary page 10…K050719 K991839 K990311 7.2 Comparison with predicate Device : Similarities Item ABX PENTRA DX 120 (K991839)… | 1999 |
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 24 years and passes through 4 companies; a new generation was cleared every 3.0 years on median.
- 8 of the 22 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. 2015, 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 PENTRA XLR is a quantitative multi-parameter automated hematology analyzer for in vitro diagnostic use in clinical laboratories to identify and enumerate the following parameters: WBC, RBC, HGB, HCT, MCV, MCH, MCHC, RDW, PLT, MPV, LYM (#, %), MON (#, %), NEU (#, %), EOS (#, %), BAS (#, %), as well as the Reticulocyte parameters RET (#, %), CRC, and IRF in K2EDTA and K3EDTA anticoagulated venous whole blood samples from patients ≥ 18 years of age.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K151133 · printed Nov 6, 2026
Cite this page
510(k) Report. “K151133: Pentra XLR.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K151133
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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