Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
GKZ — Predicate Candidate Screening
380 FDA 510(k) clearances under this product code; the 50 most recent screened below.
106 daysmedian FDA review time
389 days90th percentile
380clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K253212 | XR-Series (XR-10, XR-20) Automated Hematology Analyzers | Sysmex America, Inc. | 2026-05-27 | 240 | 0 |
| K243348 | Athelas Home | Athelas, Inc. | 2026-02-06 | 466 | 0 |
| K251249 | Tru Hematology Test | Truvian Sciences, Inc. | 2026-01-16 | 268 | 0 |
| K250943 | Sysmex XR-Series (XR-10) Automated Hematology Analyzer | Sysmex America, Inc. | 2025-06-25 | 89 | 0 |
| K251371 | Sysmex XR-Series (XR-20) Automated Hematology Analyzer | Sysmex America, Inc. | 2025-06-25 | 54 | 0 |
| K243283 | Alinity h-series System | Abbott Laboratories | 2025-02-20 | 126 | 1 |
| K240402 | Cito CBC System | Cytochip, Inc. | 2025-02-03 | 360 | 0 |
| K240252 | UniCel DxH 900 Coulter Cellular Analysis System; UniCel DxH | Beckman Coulter, Inc. | 2024-07-05 | 157 | 2 |
| K232946 | Yumizen H2500 | HORIBA ABX SAS | 2024-05-21 | 244 | 0 |
| K240636 | HemoScreen Hematology Analyzer | Pixcell Medical Technologies | 2024-05-02 | 57 | 0 |
| K230887 | Sysmex XQ-Series (XQ-320) Automated Hematology Analyzer | Sysmex America, Inc. | 2023-12-21 | 265 | 0 |
| K230878 | QScout Lab; QScout RLD | Ad Astra Diagnostics, Inc. | 2023-11-14 | 229 | 0 |
| K222148 | HemoScreen Hematology Analyzer | Pixcell Medical Technologies, Ltd. | 2023-08-16 | 392 | 0 |
| K220031 | Alinity h-series System | Abbott Laboratories | 2023-08-04 | 576 | 2 |
| K210346 | Sysmex XW-100 Automated Hematology Analyzer | Sysmex America, Inc. | 2022-11-08 | 638 | 0 |
| K211840 | Sight OLO | S.D. Sight Diagnostics , Ltd. | 2022-05-09 | 329 | 1 |
| K200828 | Athelas Home | Athelas, Inc. | 2022-03-22 | 722 | 0 |
| K193124 | Unicel DxH 800 Coulter Cellular Analysis System | Beckman Coulter | 2020-04-16 | 156 | 1 |
| K190898 | Sight OLO | Sight Diagnostics , Ltd. | 2019-11-01 | 210 | 1 |
| K182886 | Cytomics FC 500 Series (MPL or MCL) Flow Cytometer | Beckman Coulter | 2019-09-06 | 326 | 0 |
| K190294 | CELL-DYN Emerald 22 AL System | Abbott Laboratories | 2019-03-15 | 32 | 0 |
| K181475 | DxH 520 Hematology Instrument | Beckman Coulter | 2019-03-01 | 270 | 0 |
| K182389 | Sysmex XN-L Automated Hematology Analyzer | Sysmex America, Inc. | 2019-01-25 | 143 | 0 |
| K181288 | Athelas One | Athelas, Inc. | 2018-11-05 | 173 | 0 |
| K180020 | HemoScreen Hematology Analyzer | Pixcell Medical Technologies, Ltd. | 2018-10-29 | 300 | 0 |
| K171655 | cobas m 511 integrated hematology analyzer | Roche Diagnostics Hematology, Inc. | 2018-03-02 | 270 | 0 |
| K172604 | XW-100 Automated Hematology Analyzer for CLIA Waived Use | Sysmex America, Inc. | 2017-11-06 | 68 | 0 |
| K170353 | ABX MICROS ES 60 OT and ABX MICROS ES 60 CT | HORIBA ABX SAS | 2017-11-01 | 271 | 0 |
| K162977 | ADVIA 2120i, ADVIA 2120 | Siemens Healthcare Diagnostics | 2017-08-11 | 289 | 0 |
| K153538 | Dextramer CMV Kit | Immudex Aps | 2017-03-02 | 448 | 0 |
| K160538 | Sysmex XN-L Automated Hematology Analyzer | Sysmex America, Inc. | 2016-12-22 | 300 | 0 |
| K162414 | UniCel DxH SlideMaker Stainer Coulter Cellular Analysis Syst | Beckman Coulter, Inc. | 2016-11-29 | 92 | 0 |
| K160429 | BC-5390 Auto Hematology Analyzer | Mindray Bio-Medical Electronics Co., Ltd. | 2016-09-01 | 198 | 0 |
| K151133 | PENTRA XLR | HORIBA ABX SAS | 2015-12-09 | 225 | 0 |
| K143577 | XW-100 Automated Hematology Analyzer, XW QC CHECK | Sysmex America, Inc. | 2015-10-12 | 299 | 0 |
| K143348 | BC-3600 Auto Hematology Analyzer | Mindray Bio-Medical Electronics Co., Ltd. | 2015-08-21 | 273 | 0 |
| K141161 | ABX MICROS ES 60 CT; (OPEN TUBE MODEL), (CLOSE TUBE MODEL) | HORIBA ABX SAS | 2014-12-20 | 229 | 0 |
| K141681 | SYSMEX XN SERIES | Sysmex America, Inc. | 2014-12-05 | 165 | 1 |
| K140911 | UNICEL DXH 800 COULTER CELLULAR ANALYSIS SYSTEM/ UNICEL DXH | Beckman Coulter, Inc. | 2014-09-05 | 149 | 9 |
| K120771 | UNICEL DXH 800 COULTER CELLULAR ANALYSIS SYSTEM | Beckman Coulter, Inc. | 2013-03-22 | 373 | 9 |
| K112605 | SYSMEX XN-SERIES | Sysmex America, Inc. | 2012-10-19 | 408 | 2 |
| K111534 | ABACUS 3CP | Diatron U.S., Inc. | 2012-08-02 | 427 | 0 |
| K112755 | ABACUS 5 | Diatron U.S., Inc. | 2012-03-27 | 188 | 0 |
| K110381 | CELL-DYN EMERALD 22 SYSTEM | Abbott Laboratories | 2011-12-22 | 315 | 0 |
| K102644 | ADVIA 2120 WITH AUTOSLIDE SYSTEM, AND ADVIA 2120I | Siemens Healthcare Diagnostics | 2011-11-23 | 435 | 1 |
| K102064 | BD FACS SAMPLE PREP ASSISTANT III (SPA III) | Becton, Dickinson & CO | 2011-03-07 | 227 | 0 |
| K100489 | DXH 300 COULTER CELLULAR ANALYSIS SYSTEM, DXH 300C COULTER C | Beckman Coulter Cellular | 2010-10-26 | 249 | 0 |
| K090346 | ADVIA 2120/2120I BODY FLUIDS | Siemens Healthcare Diagnostics | 2010-07-28 | 532 | 0 |
| K093394 | BC-3200 AUTO HEMATOLOGY ANALYZER,M-30D DILUENT, M-30R RINSE, | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2010-04-08 | 160 | 0 |
| K091313 | SYSMEX MODEL XT-4000I | Sysmex America, Inc. | 2010-03-30 | 330 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda