Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
JPK — Predicate Candidate Screening
192 FDA 510(k) clearances under this product code; the 50 most recent screened below.
45 daysmedian FDA review time
161 days90th percentile
192clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K160588 | XN CHECK BF | Streck | 2016-12-22 | 296 | 0 |
| K160590 | XN CHECK | Streck | 2016-12-22 | 296 | 0 |
| K160586 | XN-L CHECK | Streck | 2016-12-22 | 296 | 0 |
| K160606 | BC-5D Hematology Control | R&D Systems, Inc. | 2016-09-01 | 183 | 0 |
| K141964 | XN CHECK | Streck | 2014-12-05 | 140 | 0 |
| K141957 | XN CHECK BF | Streck | 2014-12-05 | 140 | 0 |
| K130962 | R&D 5D RETIC HEMATOLOGY CONTROL | R&D Systems, Inc. | 2013-07-24 | 107 | 0 |
| K120744 | XN CHECK BF | Streck | 2012-10-19 | 221 | 0 |
| K120742 | XN CHECK | Streck | 2012-10-19 | 221 | 0 |
| K101578 | R&D SYSTEMS BODY FLUID-I HEMATOLOGY CONTROL | R&D Systems, Inc. | 2011-04-28 | 325 | 0 |
| K100790 | COULTER LIN-X LINEARITY CONTROL, MODEL A81196 | Beckman Coulter, Inc. | 2010-12-21 | 274 | 0 |
| K100607 | COULTER 4C-EX 300 CELL CONTROL | Beckman Coulter, Inc. | 2010-11-18 | 260 | 0 |
| K091303 | LIQUICHEK HEMATOLOGY-16 CONTROL LV, MODEL: 295LV | Bio-Rad Laboratories | 2010-08-02 | 455 | 0 |
| K100050 | R & D SYSTEMS XERET HEMATOLOGY CONTROL | R&D Systems, Inc. | 2010-01-29 | 21 | 0 |
| K091433 | R&D SYSTEMS TETIC-I PLUS HEMOTOLOGY CONTROL | R&D Systems, Inc. | 2009-10-28 | 168 | 0 |
| K090201 | UA-CELLULAR FOR IQ | Streck | 2009-03-27 | 59 | 0 |
| K082162 | COULTER BODY FLUID CONTROL | Beckman Coulter, Inc. | 2009-02-03 | 187 | 0 |
| K081822 | COULTER 6C CELL CONTROL, MODELS 628027 & A59925 | Beckman Coulter, Inc. | 2009-01-21 | 208 | 0 |
| K081641 | COULTER LIN-X LINEARITY CONTROL | Beckman Coulter, Inc. | 2009-01-16 | 219 | 0 |
| K073178 | HCT EXTENDED HEMATOLOGY CONTROL, MODEL HCT004 | R&D Systems, Inc. | 2007-12-27 | 44 | 0 |
| K072846 | CSF AUTOMATED CONTROL, MODELS CSF001, CSF003 | R&D Systems, Inc. | 2007-11-26 | 53 | 0 |
| K072268 | HC WBC HEMATOLOGY CONTROL, MODEL: WBC00S | R&D Systems, Inc. | 2007-11-20 | 97 | 0 |
| K072096 | CBC-5D PLUS RETICS HEMATOLOGY CONTROL, MODELS: 5DR03, 5DR04 | R&D Systems, Inc. | 2007-08-20 | 20 | 0 |
| K070199 | RETIC-CHEX LINEARITY FOR BC | Streck | 2007-02-23 | 32 | 0 |
| K063218 | E-CHECK (XE) | Streck | 2006-12-14 | 51 | 0 |
| K061511 | R&D CBC-3D + CRP HEMATOLOGY CONTROL | R&D Systems, Inc. | 2006-07-10 | 39 | 0 |
| K061320 | R&D LH-NRBC HEMATOLOGY CONTROL | R&D Systems, Inc. | 2006-06-02 | 22 | 0 |
| K061064 | COULTER LIN-C LINEARITY CONTROL, MODELS 7547065, 723503 | Beckman Coulter, Inc. | 2006-05-17 | 30 | 0 |
| K060464 | COULTER 5C CELL CONTROL | Beckman Coulter, Inc. | 2006-03-28 | 34 | 0 |
| K053362 | CELL-CHEX AUTO | Streck | 2006-01-13 | 42 | 0 |
| K051706 | IQ BODY FLUIDS CONTROL | Streck | 2005-08-17 | 51 | 0 |
| K051339 | R&D CBC-4K PLUS RETICS HEMATOLOGY CONTROL | R&D Systems, Inc. | 2005-07-12 | 50 | 0 |
| K050721 | ABX ERYTROL | Horiba Abx | 2005-06-01 | 72 | 0 |
| K042836 | LIQUICHEK RETICULOCYTE CONTROL (A) | Bio-Rad | 2004-11-05 | 22 | 0 |
| K042587 | RETIC-CHEX FOR CELL-DYN | Streck Laboratories, Inc. | 2004-10-19 | 27 | 0 |
| K042336 | METER TRAX TRILEVEL, LOW LEVEL, MID LEVEL, HIGH LEVEL TRILEV | Bio-Rad Laboratories, Inc. | 2004-10-14 | 45 | 0 |
| K042094 | R&D CBC-XE HEMATOLOGY CONTROL | R&D Systems, Inc. | 2004-09-01 | 29 | 0 |
| K041457 | LIQUICHEK HEMATOLOGY CONTROL (A) | Bio-Rad | 2004-06-28 | 27 | 0 |
| K024173 | CDS 3-PD HEMATOLOGY CONTROLS | Clinical Diagnostic Solutions, Inc. | 2003-01-14 | 27 | 7 |
| K022968 | ADVIA TESTPOINT CSF CONTROL | Bayer Diagnostics Corp. | 2002-09-24 | 18 | 0 |
| K021922 | MODIFICATION TO PARA 5X | Streck Laboratories, Inc. | 2002-06-25 | 14 | 0 |
| K020229 | R & D BODY FLUID CONTROL | R&D Systems, Inc. | 2002-02-06 | 14 | 0 |
| K013898 | R&D RET-LINE KIT | R&D Systems, Inc. | 2002-01-22 | 60 | 0 |
| K013842 | IMMUNO-TROL LOW CELLS | Beckman Coulter, Inc. | 2001-12-13 | 23 | 0 |
| K011410 | PARA 5X | Streck Laboratories, Inc. | 2001-06-26 | 49 | 0 |
| K010470 | R & D 4K RETIC | R&D Systems, Inc. | 2001-05-11 | 80 | 0 |
| K010461 | ADVIA RETIC PLUS | R&D Systems, Inc. | 2001-04-03 | 46 | 0 |
| K010598 | SYNOVIALSCOPICS, SYNOVIAL FLUID CONTROL | Quantimetrix Corp. | 2001-03-23 | 23 | 1 |
| K010409 | CBC-SF | R&D Systems, Inc. | 2001-03-16 | 32 | 0 |
| K010064 | 4C-ES CELL, MODELS 7547187, 7547188, 7547189, 7547190 | Beckman Coulter, Inc. | 2001-02-07 | 30 | 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