Atlas FDA

Predicate Research Report · generated 2026-08-21 · Print / save as PDF · Save to account

JQW — Predicate Candidate Screening

140 FDA 510(k) clearances under this product code; the 50 most recent screened below.

48 daysmedian FDA review time
117 days90th percentile
140clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K023955BD VIPER INSTRUMENTBecton, Dickinson & CO2003-06-242090
K973335QUATRO SP SAMPLE PROCESSING SYSTEMS (200-499, INCLUSIVE)Zenyx Scientific , Ltd.1998-04-302380
K9801802700 SAMPLE MANAGERWaters Corporation1998-02-12230
K970420MASTERCAP AM 5.0/MASTERCAP RM 5.0Pharmacia, Inc.1997-06-301470
K970616MINI SAMPLER PROCESSORCavro Scientific Instruments, Inc.1997-04-21620
K962687GIO. DE VITA E C. S.R.L.(GDV) AUTOMATIC WASHING SYSTEMNichols Institute Diagnostics1997-03-282600
K962859MINI SAMPLE PROCESSORCavro Scientific Instruments, Inc.1996-10-29990
K961896MICROLAB 4000, MICROLAB 4200Hamilton Co.1996-08-16920
K961694IMPACTMatrix Technologies Corp.1996-06-21510
K953345GENESISTecan U.S., Inc.1995-11-211323
K951753MEDTEC AUTOBLOT 2000Medtec, Inc.1995-10-171830
K952025ROBOCAPPharmacia, Inc.1995-07-26860
K9445564 CHANNEL DISPENSERTecan U.S., Inc.1994-10-25390
K9426554 CHANNEL DISPENSERTecan U.S., Inc.1994-09-02880
K942290STAR I WORKSTATIONStandard Engineering1994-08-261070
K941498BIOMEK SL WITH BIOMEK SL INCUBATORBeckman Analytical and Biotechnology Development1994-07-141080
K941394STAT FAX 2600Awareness Technology, Inc.1994-06-03730
K940390IMPACTMatrix Technologies Corp.1994-05-03970
K936258SYSTEM WASHER 100Eg&G Berthold1994-04-261170
K934124AUTOQUOT AUTOMATED ALIQUOTTING SYSTEMAndronic Devices, Ltd.1994-04-132310
K933088PLATO 3000Rosys, Inc.1994-02-252470
K925547MAXSOFTWAREDiagnostic Products Corp.1993-01-26840
K923879ASSAY SOFTWARE FOR DPC-MARJ5 ALASTAT EIA SOFTWAREDiagnostic Products Corp.1992-12-071260
K922803WELLWASH 4 MARK IIDenley Instruments, Inc.1992-11-051480
K922327DENLEY WELLPREP 2 SAMPLE PROCESSORDenley Instruments, Inc.1992-08-12930
K922183WELLPREP 2000 SAMPLE PROCESSORDenley Instruments, Inc.1992-08-11920
K923268AFFIRM PROCESSORMicroprobe Corp.1992-07-30240
K921005AUTOLOADERInnovative Medical Systems, Inc.1992-04-29570
K915492RSP MEGA SAMPLE PROCESSORTecan U.S., Ltd.1992-02-21790
K915284STACKING MICROPLATE WASHERDenley Instruments, Inc.1992-01-22580
K913809HY-PREP SYSTEMHyperion, Inc.1992-01-151420
K913567WELLPREP 1Denley Instruments, Inc.1991-10-04560
K913664ROSYS MODELS 100 AND 200Packard Instrument Co., Inc.1991-08-30140
K912036ROBOTIC SAMPLE PROCESSORTecan U.S., Ltd.1991-07-26790
K912228MARK 5 ROBOTIC PIPETTORDiagnostic Products Corp.1991-06-06170
K911712STRATUS(R) AUTOMATED SAMPLE HANDLERBaxter Healthcare Corp1991-05-15280
K910140ELECTRAPETTE (R)Matrix Technologies Corp.1991-02-04210
K902592EPC ELECTRONIC PIPETTING SYSTEMUlster Scientific, Inc.1990-07-19370
K900599MICROPLATE REAGENT DISPENSERDenley Instruments, Inc.1990-05-17980
K896684KEMBLE LIQUID HANDLING SYSTEM DISPENSERSchiff & Co.1990-04-161390
K896631EXEC-WASH SOLID PHASE WASHING SYSTEMSource Scientific Systems, Inc.1990-04-031320
K900775NOVAPATH SP ADVANCED LIQUID HANDLING SYSTEMBio-Rad1990-03-09170
K897158ABBOTT COMMANDER PARALLEL PROCESSING CENTERAbbott Laboratories1990-03-01650
K893811SAKURA PREP AI AUTOMATIC LIQUID HANDLING SYSTEMSakura Finetek U.S.A., Inc.1989-09-071080
K894710DPC-ROBOSTAT(TM)Diagnostic Products Corp.1989-08-31380
K894069ABBOTT COMMANDER FLEXIBLE PIPETTING CENTERAbbott Laboratories1989-08-21741
K894272DENLEY WELLDILL 3Denley Instruments, Inc.1989-08-21600
K894126ROBOTIC SAMPLE PROCESSORTecan U.S., Ltd.1989-08-15640
K894271DENLEY WELLWASH 2 AND 4Denley Instruments, Inc.1989-08-15540
K893810IMMUNO-WASH AUTOMATED TUBE WASHEROcean Scientific, Inc.1989-08-03730

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