Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
R&D Systems, Inc. — Predicate Candidate Screening
79 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
50 daysmedian FDA review time
153 days90th percentile
79clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K160606 | BC-5D Hematology Control | R&D Systems, Inc. | 2016-09-01 | 183 | 0 |
| K130962 | R&D 5D RETIC HEMATOLOGY CONTROL | R&D Systems, Inc. | 2013-07-24 | 107 | 0 |
| K101578 | R&D SYSTEMS BODY FLUID-I HEMATOLOGY CONTROL | R&D Systems, Inc. | 2011-04-28 | 325 | 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 |
| 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 |
| K070334 | R&D SICKLE QC CONTROL | R&D Systems, Inc. | 2007-03-29 | 52 | 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 |
| K051339 | R&D CBC-4K PLUS RETICS HEMATOLOGY CONTROL | R&D Systems, Inc. | 2005-07-12 | 50 | 0 |
| K042094 | R&D CBC-XE HEMATOLOGY CONTROL | R&D Systems, Inc. | 2004-09-01 | 29 | 0 |
| K034048 | R&D GLU-LINE HEMATOLOGY CONTROL | R&D Systems, Inc. | 2004-03-10 | 71 | 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 |
| 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 |
| K010409 | CBC-SF | R&D Systems, Inc. | 2001-03-16 | 32 | 0 |
| K003991 | CD-CAL PLUS CALIBRATOR | R&D Systems, Inc. | 2001-01-16 | 21 | 0 |
| K003874 | CBC-4K HEMATOLOGY CONTROL | R&D Systems, Inc. | 2001-01-12 | 28 | 0 |
| K003534 | PENTRA 5D | R&D Systems, Inc. | 2000-12-01 | 15 | 0 |
| K003208 | R & D 3K RETIC | R&D Systems, Inc. | 2000-11-07 | 25 | 0 |
| K993321 | R&D HGB/GLC WHOLE BLOOD CONTROL | R&D Systems, Inc. | 1999-11-12 | 39 | 0 |
| K991876 | SEDRITE PLUS ERYTHROCYTE SEDIMENTATION RATE | R&D Systems, Inc. | 1999-06-17 | 15 | 0 |
| K983032 | CBC-5D HEMATOLOGY CONTROL | R&D Systems, Inc. | 1999-02-17 | 170 | 0 |
| K984099 | QBC CENTRIFUGAL HEMATOLOGY CONTROL | R&D Systems, Inc. | 1998-12-10 | 23 | 0 |
| K982231 | STATUSFLOW | R&D Systems, Inc. | 1998-07-20 | 25 | 1 |
| K972172 | ESR CONTROL-M HEMATOLOGY ERYTHROCYTE SEDIMENTATION | R&D Systems, Inc. | 1997-07-24 | 45 | 0 |
| K972170 | ESR CONTROL-HC HEMATOLOGY ERYTHROCYTE SEDIMENTATION | R&D Systems, Inc. | 1997-07-24 | 45 | 0 |
| K964767 | QUANTIKINE IVD BETA-2-MICROGLOBULIN ENZYME IMMUNOASSAY (EIA( | R&D Systems, Inc. | 1997-05-29 | 183 | 0 |
| K970718 | QUANTIKINE IVD STFR ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA | R&D Systems, Inc. | 1997-05-27 | 90 | 1 |
| K970331 | CBC-4K HEMATOLOGY CONTROL | R&D Systems, Inc. | 1997-04-16 | 78 | 0 |
| K961673 | R&D RETIC-PG HEMATOLOGY CONTROL | R&D Systems, Inc. | 1996-07-15 | 75 | 0 |
| K961610 | R & D SYSTEMS' WHOLE BLOOD FLOW CONTROL, (R & D - WBFC) | R&D Systems, Inc. | 1996-07-01 | 67 | 0 |
| K955925 | CBC-CAL PLUS HEMATOLOGY CALIBRATOR | R&D Systems, Inc. | 1996-02-29 | 69 | 0 |
| K954137 | QBC CENTRIFUGAL HEMATOLOGY CONTROL | R&D Systems, Inc. | 1995-10-06 | 35 | 0 |
| K943335 | RETIC CONTROL-M HEMATOLOGY CONTROL/MULTIPLE | R&D Systems, Inc. | 1994-12-12 | 153 | 0 |
| K943336 | RETIC CONTROL-H HEMATOLOGY CONTROL/MULTIPLE | R&D Systems, Inc. | 1994-12-12 | 153 | 0 |
| K942822 | CBC-LINE HEMATOLOGY LINEARITY CONTROL | R&D Systems, Inc. | 1994-10-07 | 114 | 0 |
| K936016 | QUANTIKINE IVD ERYTHROPOIETIN ENZYME LINKED IMMUNOSORBENT AS | R&D Systems, Inc. | 1994-07-19 | 215 | 0 |
| K931756 | QUANTIKINE(TM) ERYTHROPOIETIN HUMAN SERUM CONTROLS | R&D Systems, Inc. | 1994-04-21 | 378 | 1 |
| K940089 | CBC-COBAS 5 HEMATOLOGY CONTROL/MULTIPLE | R&D Systems, Inc. | 1994-03-22 | 74 | 0 |
| K934497 | CBC-STK(TM) HEMATOLOGY CONTROL/MULTIPLE | R&D Systems, Inc. | 1993-12-06 | 83 | 0 |
| K931666 | QUANTIKINE(TM) ERYTHROPOIETIN/ENZ LINK IMMUN ASSAY | R&D Systems, Inc. | 1993-07-20 | 105 | 0 |
| K913879 | CBC-8K(TM) HEMATOLOGY CONTROL/MULTIPLE | R&D Systems, Inc. | 1991-11-27 | 90 | 0 |
| K912357 | 3K-CAL HEMATOLOGY CALIBRATOR/MULTIPLE | R&D Systems, Inc. | 1991-07-09 | 42 | 0 |
| K904637 | QBC(R) CENTRIFUGAL HEMATOLOGY CONTROL/MULTIPLE | R&D Systems, Inc. | 1990-10-29 | 18 | 0 |
| K904464 | CBC-LASER(R) HEMATOLOGY CONTROL/MULTIPLE-MODIFIED | R&D Systems, Inc. | 1990-10-23 | 22 | 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