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Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

Bio-Tek Instruments, Inc. — Predicate Candidate Screening

37 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.

63 daysmedian FDA review time
286 days90th percentile
37clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K973609IDA-4 AND IPT-MCBio-Tek Instruments, Inc.1997-12-18870
K971273INDEX 2E, INDEX 2F, INDEX 2EF, CARDIOSAT 100E, CARDIOSAT 100Bio-Tek Instruments, Inc.1997-10-081840
K961862MODELS IDA-2 PLUS AND IPT-1Bio-Tek Instruments, Inc.1997-02-262880
K954391MODELS QED-6, 6M AND 6H DEFIBRILLATOR ANALYZER WITH OPTIONALBio-Tek Instruments, Inc.1995-11-17590
K953710ELX808 AUTOMATED MICROPLATE READERSBio-Tek Instruments, Inc.1995-10-25771
K953572ELX800UVBio-Tek Instruments, Inc.1995-10-19800
K950104ELX800 AND EL800 AUTOMATED MICROPLATE READERSBio-Tek Instruments, Inc.1995-03-21691
K942923CERES 900C & CERES UV900CBio-Tek Instruments, Inc.1995-02-062300
K944257LIONHEART 3 MULTI-PARAMETER SIMULATORBio-Tek Instruments, Inc.1994-09-21210
K933519INDEX SPO2 SIMULATORBio-Tek Instruments, Inc.1994-09-014080
K933548ELS 1000Bio-Tek Instruments, Inc.1993-10-291010
K925625OMNIBio-Tek Instruments, Inc.1993-08-192860
K921074BP PUMPBio-Tek Instruments, Inc.1992-10-092170
K914906AUTO EIA MICROPLATE READ MODEL CERES 900 W/VAR OPTBio-Tek Instruments, Inc.1991-11-27260
K903966EXTERNAL PACEMAKER ANALYZER MODEL PMA-1Bio-Tek Instruments, Inc.1991-06-192950
K911438TURBO ACCELERATOR W/CLIN DIAG SOFTWARE CARTRIDGEBio-Tek Instruments, Inc.1991-05-23510
K904159DEFIBRILLATOR ANALYZER MODEL QED-5Bio-Tek Instruments, Inc.1991-03-181880
K901059AUTOMATED EIA MICROPLATE READER MODELS EL340/340IBio-Tek Instruments, Inc.1990-04-09340
K901027AUTOMATED EIA MICROPLATE READER MODELS EL312/312IBio-Tek Instruments, Inc.1990-04-09340
K900579AUTOREADER CALIBRATION TEST PLATEBio-Tek Instruments, Inc.1990-02-27200
K893660ECG SIMULATOR MODEL ECGPLUSBio-Tek Instruments, Inc.1989-12-052040
K893659ELECTROSURGERY ANALYZER RF302Bio-Tek Instruments, Inc.1989-07-14600
K890854EIA READER MODEL EL301Bio-Tek Instruments, Inc.1989-03-16230
K884124AUTOMATED EIA READER MODEL EL311Bio-Tek Instruments, Inc.1989-01-03950
K884125BIO-TEK AUTOMATED MICROPLATE WASHER MODEL EL403Bio-Tek Instruments, Inc.1988-12-02631
K871619LPM-1 (LASER POWER METER)Bio-Tek Instruments, Inc.1987-07-28920
K862932THE BIO-TEK UW-IIBio-Tek Instruments, Inc.1986-09-25520
K862344GOULD XCALIBERBio-Tek Instruments, Inc.1986-08-06470
K853760ADULT VENTILATOR TESTER VT-1Bio-Tek Instruments, Inc.1985-12-03850
K853920BIO-TEK EL 401 HANDHELD MICROPLATE WASHERBio-Tek Instruments, Inc.1985-10-22290
K850249BIO-TEK AUTOMATED MICROPLATE WASHER EL402Bio-Tek Instruments, Inc.1985-03-13500
K842085AUTOMATED EIA MICROPLATE READER EL310Bio-Tek Instruments, Inc.1984-06-11180
K831522BIO-TEK PERCENT OXYGEN MONITOR 74222Bio-Tek Instruments, Inc.1983-09-121230
K837605MV/CM2 NUMBER X74294 MODEL NUMBER 74229Bio-Tek Instruments, Inc.1983-06-28430
K810363EAR OXIMETERBio-Tek Instruments, Inc.1981-02-27160
K803030THE BIO-TEK CHROMOSCANBio-Tek Instruments, Inc.1980-12-22240
K800591CONTOUROGRAPH M-500Bio-Tek Instruments, Inc.1980-04-02160

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