Atlas FDA

JQP

78 FDA 510(k) clearances · Product code

39 daysmedian time to decision
143 days90th percentile
78clearances measured

FDA profile

Official device name
Calculator/Data Processing Module, For Clinical Use
Device class
Class I (low risk)
Regulation
21 CFR 862.2100
Medical specialty
Clinical Chemistry
Adverse events (MAUDE)
2021: 105 · 2022: 166 · 2023: 171 · 2024: 102 · 2025: 119 · 2026: 45
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free

RecordFirmDate
BIONIME DIABETES MANAGEMENT SYSTEM VI.0 (K113007)Bionime Corporation2012-02-27
FASTTAKE ADAPTER, MODEL # P/N 020-072-01 (K983468)Selfcare, Inc.1998-12-17
THE ROBOLITE (K964460)Shai Syg Motion and Innovations, Ltd.1997-01-24
PRENVAL I (K953652)Base Ten Systems, Inc.1995-09-15
MR7000 WITH TIME MANAGER SOFTWARE (TMS) (K934111)Dynatech Laboratories, Inc.1994-11-02
EXPRESSO CARTRIDGE (K923316)Bio-Rad Laboratories, Inc.1993-02-23
MODIFIED MODEL 570 CLINICAL CHEMISTRY ANALYZER (K893838)Ciba Corning Diagnostics Corp.1989-08-31
CYBERLAB HIGH VOLUME DRUG TESTING SYSTEM (K892060)Syva Co.1989-08-10
COBAS MFC (K885292)Roche Diagnostic Systems, Inc.1989-03-22
RIA-QUICK (K881194)Quantitative Technologies, Inc.1988-06-01
V-MARC 88A COMPUTER (K871853)V.Marc, A Div. of Pictorial, Inc.1987-07-16
KALLESTAD QM300 PROTEIN ANALYSIS SYSTEM (K871339)Kallestad Diag, A Div. of Erbamont, Inc.1987-05-15
710 PLUS (K864557)Ciba Corning Diagnostics Corp.1987-02-25
GLUCOFACTS DATA MANAGEMENT SYSTEM (K861844)Miles Laboratories, Inc.1986-08-12
GLUCOFACTS DATA PRINTER (K861779)Miles Laboratories, Inc.1986-08-08
CLINIFACTS 200 DATA MANAGEMENT SYSTEM (K861778)Miles Laboratories, Inc.1986-07-02
DIRECT READOUT MODULE ACCESSORY (K861412)E.I. Dupont DE Nemours & Co., Inc.1986-05-23
SIMULATOR (K854265)Cygnus of South Florida, Inc.1986-03-18
BIOVATION MAX DATA MANAGEMENT SYSTEM (K853026)Biovation, Inc.1985-08-02
ATAC 2000 CHEMISTRY ANALYZER (K851321)Turpen Laboratory Systems, Inc.1985-04-25
SYVA 700 SYSTEM ACCESSORIES-CLINICAL CHEM ANALYZER (K850659)Syva Co.1985-04-01
CLINIFACTS 10 DATA MANAGEMENT SYSTEM (K844907)Miles Laboratories, Inc.1985-01-18
ISO-DATA IMMUNOASSAY NETWORK SYSTEM (K843365)Iso-Data, Inc.1984-09-27
CHEMISTRY CONSOLE (K842401)Biovation, Inc.1984-09-04
LYRIS MODULAR INFO SYSTEM (K831830)Biovation, Inc.1984-06-25
GELSCAN SOFTWARE 2190 (K834490)Lkb Instruments, Inc.1984-05-01
CATS-CLINICAL LAB COMPUTER SOFTWARE- (K840502)Precision Technology, Inc.1984-04-04
HYBRITECH DATA STATION (K834300)Hybritech, Inc.1984-02-21
LABORATORY DATA MGMT SYSTEM SDMS (K831838)Vickers America Medical Corp.1984-01-24
ACLAIM-QAP IBM PERSONAL COMPUTER EDT (K833353)American Dade1983-12-22
DUPONT LINEARIZATION MODULE (K832746)E.I. Dupont DE Nemours & Co., Inc.1983-11-25
RIA SOFTWARE (K832760)Kemble Instruments, Inc.1983-10-14
BLOOD GAS QUALITY CONTROL SOFT-86000F (K831574)Computermate, Inc.1983-10-14
CORNING 102 PRINTER (K830296)Corning Medical & Scientific1983-03-25
API MDS* (K823785)Analytical Products, Inc.1983-01-09
NML 6000 CT (K823679)Nuclear Medical Laboratories, Inc.1983-01-07
BLOOD GAS EXPER. SYSTEM 8700 (K822778)Exper Corp., Inc.1982-12-03
QAP MICROCOMPUTER SYSTEM (K823110)American Dade1982-11-16
EMIT CLINICAL PROCESSOR #CP-5000 (K822932)Syva Co.1982-11-05
RIA SSIST TI-59 MAGNETIC CARD PROGRAMS (K822860)Ventrex Laboratories, Inc.1982-10-27
SYVA LAB PROCESSOR 6000 (K822381)Syva Co.1982-08-27
CORNING 101 PRINTER (K822146)Corning Medical & Scientific1982-08-05
AMERIFLOUR FLUOROMETER (K821807)American Diagnostic Corp.1982-07-02
EMIT TIMER UNIT #100 (K821531)Syva Co.1982-06-11
715 DELTA TERMINAL (K821058)Corning Medical & Scientific1982-05-03
COMPUTERIZED INTERPRETATION OF ARTERIAL (K820721)Philip R. Corsello, M.D.1982-04-01
IL 8060 DATA MANAGEMENT SYSTEM (K820427)Instrumentation Laboratory CO1982-03-11
BIOVATION URINALYSIS REPORTER (K812604)Biovation, Inc.1981-10-02
BCD-HPP41C INTERFACE (K810968)Dynatech Corp.1981-04-23
DPM CALCULATOR (K810631)Iso-Data, Inc.1981-03-27
MICROMEDIC AUTOMATIC COMPUTING CENTER (K803312)Micomedic Systems1981-02-04
AUTOMATIC BIOCHEMICAL ANALYZER (K810063)Acculab1981-01-26
BECKMAN DP-5500 DATA REDUCTION SYSTEM (K802594)Beckman Instruments, Inc.1980-11-12
CHEMTROLER (K802471)Fletcher Flora Computer Products, Inc.1980-11-12
SP 120 SOPHISTICATE (K802251)Vickers America Medical Corp.1980-10-23
SERALYZER GLUCOSE TEST MODULE (K801664)Miles Laboratories, Inc.1980-08-20
CENTRIFICHEM SYSTEM MANAGER (K801438)Union Carbide Corp.1980-07-28
BIOSTATOR PRINTER/PLOTTER (K801210)Miles Laboratories, Inc.1980-06-17
K 750 COMPUTER/DATA PROCESSOR (K801091)J.T. Baker Chemical Co.1980-06-09
CENTRIFICHEM SYSTEM 400 (K801167)Union Carbide Corp.1980-06-09
IL88640 & 88641 CASSETTE-TAPE PROGRAM (K801131)Instrumentation Laboratory CO1980-05-23
AMES LAB MANAGEMENT SYSTEM (K800724)Miles Laboratories, Inc.1980-04-16
DATA MANAGEMENT SYSTEM IL MODEL 775 (K800282)Instrumentation Laboratory CO1980-03-05
MICRO MEDICAL DATA SYSTEM II (K800242)Micro/Tel., Inc.1980-03-03
MICRO MEDICAL DATA SYSTEM (K800241)Micro/Tel., Inc.1980-02-26
3388 REPORTING INTEGRATOR (K792158)Hewlett-Packard Co.1979-11-16
EMIT CLINICAL PROCESSOR-CP 5000 (K792129)Syva Co.1979-11-13
THE ABBOTT EXECUTIVE (K790543)Abbott Laboratories1979-05-03
UNION CARBIDE CORP. COMPUTER INTERFACE (K790336)Union Carbide Corp.1979-04-04
PROCESSOR, K750 COMPUTER/DATA (K782052)Kallestad Laboratories, Inc.1979-01-17
EMIT MCA PROGRAM TAPE (K781081)Instrumentation Laboratory CO1978-09-27
COMPUTER INTERFACE IL 814 (K781173)Instrumentation Laboratory CO1978-09-14
DATA TERMINAL MODEL 722 (K781217)Corning Medical & Scientific1978-08-21
EMIT CLINICAL PROCESSOR - CP 5000 (K780881)Syva Co.1978-06-22
DATA REDUCTION SYSTEM, DP-3000 (K770877)Beckman Instruments, Inc.1977-07-21
CALCULATOR, ENZYME, TURNER (K770671)Turner Assoc.1977-06-27
GAMMACORD II CALCULATOR INTERFACE (K761063)Miles Laboratories, Inc.1976-12-02
ACA DATA MATE ACCESSORY (K760739)E.I. Dupont DE Nemours & Co., Inc.1976-11-16

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Every clearance here is in the API, with alerts when new ones post.