Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
JQP — Predicate Candidate Screening
78 FDA 510(k) clearances under this product code; the 50 most recent screened below.
39 daysmedian FDA review time
143 days90th percentile
78clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K113007 | BIONIME DIABETES MANAGEMENT SYSTEM VI.0 | Bionime Corporation | 2012-02-27 | 143 | 0 |
| K983468 | FASTTAKE ADAPTER, MODEL # P/N 020-072-01 | Selfcare, Inc. | 1998-12-17 | 77 | 0 |
| K964460 | THE ROBOLITE | Shai Syg Motion and Innovations, Ltd. | 1997-01-24 | 78 | 0 |
| K953652 | PRENVAL I | Base Ten Systems, Inc. | 1995-09-15 | 39 | 0 |
| K934111 | MR7000 WITH TIME MANAGER SOFTWARE (TMS) | Dynatech Laboratories, Inc. | 1994-11-02 | 456 | 0 |
| K923316 | EXPRESSO CARTRIDGE | Bio-Rad Laboratories, Inc. | 1993-02-23 | 231 | 0 |
| K893838 | MODIFIED MODEL 570 CLINICAL CHEMISTRY ANALYZER | Ciba Corning Diagnostics Corp. | 1989-08-31 | 99 | 0 |
| K892060 | CYBERLAB HIGH VOLUME DRUG TESTING SYSTEM | Syva Co. | 1989-08-10 | 134 | 0 |
| K885292 | COBAS MFC | Roche Diagnostic Systems, Inc. | 1989-03-22 | 85 | 0 |
| K881194 | RIA-QUICK | Quantitative Technologies, Inc. | 1988-06-01 | 72 | 0 |
| K871853 | V-MARC 88A COMPUTER | V.Marc, A Div. of Pictorial, Inc. | 1987-07-16 | 65 | 0 |
| K871339 | KALLESTAD QM300 PROTEIN ANALYSIS SYSTEM | Kallestad Diag, A Div. of Erbamont, Inc. | 1987-05-15 | 43 | 0 |
| K864557 | 710 PLUS | Ciba Corning Diagnostics Corp. | 1987-02-25 | 98 | 0 |
| K861844 | GLUCOFACTS DATA MANAGEMENT SYSTEM | Miles Laboratories, Inc. | 1986-08-12 | 91 | 0 |
| K861779 | GLUCOFACTS DATA PRINTER | Miles Laboratories, Inc. | 1986-08-08 | 92 | 0 |
| K861778 | CLINIFACTS 200 DATA MANAGEMENT SYSTEM | Miles Laboratories, Inc. | 1986-07-02 | 55 | 0 |
| K861412 | DIRECT READOUT MODULE ACCESSORY | E.I. Dupont DE Nemours & Co., Inc. | 1986-05-23 | 38 | 0 |
| K854265 | SIMULATOR | Cygnus of South Florida, Inc. | 1986-03-18 | 146 | 0 |
| K853026 | BIOVATION MAX DATA MANAGEMENT SYSTEM | Biovation, Inc. | 1985-08-02 | 15 | 0 |
| K851321 | ATAC 2000 CHEMISTRY ANALYZER | Turpen Laboratory Systems, Inc. | 1985-04-25 | 23 | 0 |
| K850659 | SYVA 700 SYSTEM ACCESSORIES-CLINICAL CHEM ANALYZER | Syva Co. | 1985-04-01 | 40 | 0 |
| K844907 | CLINIFACTS 10 DATA MANAGEMENT SYSTEM | Miles Laboratories, Inc. | 1985-01-18 | 32 | 0 |
| K843365 | ISO-DATA IMMUNOASSAY NETWORK SYSTEM | Iso-Data, Inc. | 1984-09-27 | 30 | 0 |
| K842401 | CHEMISTRY CONSOLE | Biovation, Inc. | 1984-09-04 | 77 | 0 |
| K831830 | LYRIS MODULAR INFO SYSTEM | Biovation, Inc. | 1984-06-25 | 384 | 0 |
| K834490 | GELSCAN SOFTWARE 2190 | Lkb Instruments, Inc. | 1984-05-01 | 147 | 0 |
| K840502 | CATS-CLINICAL LAB COMPUTER SOFTWARE- | Precision Technology, Inc. | 1984-04-04 | 58 | 0 |
| K834300 | HYBRITECH DATA STATION | Hybritech, Inc. | 1984-02-21 | 74 | 0 |
| K831838 | LABORATORY DATA MGMT SYSTEM SDMS | Vickers America Medical Corp. | 1984-01-24 | 231 | 0 |
| K833353 | ACLAIM-QAP IBM PERSONAL COMPUTER EDT | American Dade | 1983-12-22 | 85 | 0 |
| K832746 | DUPONT LINEARIZATION MODULE | E.I. Dupont DE Nemours & Co., Inc. | 1983-11-25 | 102 | 0 |
| K832760 | RIA SOFTWARE | Kemble Instruments, Inc. | 1983-10-14 | 56 | 0 |
| K831574 | BLOOD GAS QUALITY CONTROL SOFT-86000F | Computermate, Inc. | 1983-10-14 | 151 | 0 |
| K830296 | CORNING 102 PRINTER | Corning Medical & Scientific | 1983-03-25 | 57 | 0 |
| K823785 | API MDS* | Analytical Products, Inc. | 1983-01-09 | 24 | 0 |
| K823679 | NML 6000 CT | Nuclear Medical Laboratories, Inc. | 1983-01-07 | 31 | 0 |
| K822778 | BLOOD GAS EXPER. SYSTEM 8700 | Exper Corp., Inc. | 1982-12-03 | 80 | 0 |
| K823110 | QAP MICROCOMPUTER SYSTEM | American Dade | 1982-11-16 | 26 | 0 |
| K822932 | EMIT CLINICAL PROCESSOR #CP-5000 | Syva Co. | 1982-11-05 | 32 | 0 |
| K822860 | RIA SSIST TI-59 MAGNETIC CARD PROGRAMS | Ventrex Laboratories, Inc. | 1982-10-27 | 30 | 0 |
| K822381 | SYVA LAB PROCESSOR 6000 | Syva Co. | 1982-08-27 | 18 | 0 |
| K822146 | CORNING 101 PRINTER | Corning Medical & Scientific | 1982-08-05 | 15 | 0 |
| K821807 | AMERIFLOUR FLUOROMETER | American Diagnostic Corp. | 1982-07-02 | 15 | 0 |
| K821531 | EMIT TIMER UNIT #100 | Syva Co. | 1982-06-11 | 21 | 0 |
| K821058 | 715 DELTA TERMINAL | Corning Medical & Scientific | 1982-05-03 | 18 | 0 |
| K820721 | COMPUTERIZED INTERPRETATION OF ARTERIAL | Philip R. Corsello, M.D. | 1982-04-01 | 16 | 0 |
| K820427 | IL 8060 DATA MANAGEMENT SYSTEM | Instrumentation Laboratory CO | 1982-03-11 | 22 | 0 |
| K812604 | BIOVATION URINALYSIS REPORTER | Biovation, Inc. | 1981-10-02 | 17 | 0 |
| K810968 | BCD-HPP41C INTERFACE | Dynatech Corp. | 1981-04-23 | 14 | 0 |
| K810631 | DPM CALCULATOR | Iso-Data, Inc. | 1981-03-27 | 17 | 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