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

Kontron Instruments, Inc. — Predicate Candidate Screening

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

156 daysmedian FDA review time
407 days90th percentile
57clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K932268MODIFICATIONS TO INTRA-AORTIC BALLOONSKontron Instruments, Inc.1993-12-152590
K925248MODIFICATION OF INTRA-AORTIC BALLOON CATHETERSKontron Instruments, Inc.1993-09-273460
K923603INTRA-AORTIC BALLOON PUMP CATHETER - MODIFICATIONKontron Instruments, Inc.1993-03-082490
K905313KONTRON INTRA-AORTIC BALLOON PUMP, MODEL KAAT IIKontron Instruments, Inc.1991-06-192030
K9033449.5 FR PERCUTANEOUS DB LUMEN 40CC FLEXI-CATH (TM)Kontron Instruments, Inc.1991-01-151740
K896437KONTRON SIGMA 44 HVCD ULTRASOUND IMAGING SYSTEMKontron Instruments, Inc.1990-12-033890
K8922229.5F PERCU DOUBLE LUMEN INTRA-AORTIC BALLOONKontron Instruments, Inc.1990-09-145290
K882955SUPERMON NEONATAL NON-INVASIVE BLOOD PRESS. 7283Kontron Instruments, Inc.1990-01-265610
K896386MINIMON 7133B PATIENT MONITORKontron Instruments, Inc.1989-12-13370
K896417KONTRON KOLORMON 7250 PATIENT MONITORKontron Instruments, Inc.1989-12-12340
K895425MINIMON 7137B PATIENT MONITORKontron Instruments, Inc.1989-09-26190
K8927989 FR PERCUTAN DOUBLE LUMEN INTRA-AORTIC BALLOONKontron Instruments, Inc.1989-09-201560
K8927998 FR PERCUTAN DOUBLE LUMEN INTRA-AORTIC BALLOONKontron Instruments, Inc.1989-09-201560
K89279710 FR PERCUTAN DOUBLE LUMEN INTRA-AORTIC BALLOONKontron Instruments, Inc.1989-09-201560
K892878KONTRON INTRA-AORTIC BALLOON PUMP MODEL K9000Kontron Instruments, Inc.1989-09-131470
K882206SUPERMON ARRHYTHMIA MODULE 7270Kontron Instruments, Inc.1989-04-053140
K8825089.5 FRENCH PERCUTANEOUS DOUBLE LUMEN BALLOONKontron Instruments, Inc.1989-03-202760
K88227410.5 FRENCH PERCUTANEOUS DOUBLE LUMEN INTRA-AORTICKontron Instruments, Inc.1989-03-202930
K890299KONTRON PULSE OXIMETER 7840Kontron Instruments, Inc.1989-03-02420
K883069MINIMON 7134B PATIENT MONITORKontron Instruments, Inc.1989-01-171810
K873624KONTRON PULSE OXIMETER 7840Kontron Instruments, Inc.1988-10-194070
K882197MINIMON 7131B PATIENT MONITORKontron Instruments, Inc.1988-08-12790
K882198MINIMON 7132B PATIENT MONITORKontron Instruments, Inc.1988-07-28640
K882673SIGMA 1 WOBBLER BIOPSY KITKontron Instruments, Inc.1988-07-28300
K873396KONTRON CAPNOGRAPH MONITOR, SUPERMON MODULE 7281Kontron Instruments, Inc.1988-06-213020
K875036INTRA-AORTIC BALLOON PUMP MODEL KAATKontron Instruments, Inc.1988-05-181630
K874816KONTRON INTRA-AORTIC BALLOON PUMP MODEL K2000Kontron Instruments, Inc.1988-04-011200
K875334KONTRON SIGMA 1 DIGITAL ECHOCARDIOGRAPH SYSTEMKontron Instruments, Inc.1988-03-24850
K875371KONTRON SIGMA 1 DIGITAL ECHOCARDIOGRAPH SYSTEMKontron Instruments, Inc.1988-03-24840
K870816KONTRON STRESSDATA STRESS DATA MANAGEMENT SYSTEMKontron Instruments, Inc.1988-03-013640
K870815KONTRON E.E.G. MONITOR, SUPERMON MODULE 7265Kontron Instruments, Inc.1988-02-013350
K861374SUPERMON NON-INVASIVE BLOOD PRESSURE MODULE 7282Kontron Instruments, Inc.1987-07-214660
K862686KONTRON SIGMA 1SC DIGITAL ECHOCARDIOGRAPHY SYSTEMKontron Instruments, Inc.1987-02-272270
K862261KONTRON SUPERMON CARDIAC OUTPUT MODULE 7263Kontron Instruments, Inc.1987-02-192510
K852249KONTRON VITALMON 5010 PATIENT MONITORKontron Instruments, Inc.1986-10-165110
K860638NOVEMPERC DOUBLE LUMEN INTRA-AORTIC BALLOONKontron Instruments, Inc.1986-10-012230
K860427KONTRON INTRA-AORTIC BALLOON PUMP MODEL KAATKontron Instruments, Inc.1986-05-07920
K860951KONTRON CUTANEOUS PO2 MONITOR 820Kontron Instruments, Inc.1986-04-09280
K853062INTRA-AORTIC BALLOON PUMP MODEL K2000Kontron Instruments, Inc.1986-01-221870
K854307KONTRON DEFIBRILLATOR 7501Kontron Instruments, Inc.1985-12-04400
K852543KONTRON SIGMA ISC ECHOCARDIOGRAPH SYSTEMKontron Instruments, Inc.1985-09-20980
K842422KONTRON FAX FETAL MONITORKontron Instruments, Inc.1985-09-204570
K844731KONTRON SUPERMON 7210 PATIENT MONITORKontron Instruments, Inc.1985-05-161630
K844215KONTRON MINIMON 7134 PATIENT MONITORKontron Instruments, Inc.1985-04-041550
K844732KONTRON MINIMON 7132 PATIENT MONITORKontron Instruments, Inc.1985-03-271130
K844733KONTRON MINIMON 7131 PATIENT MONITORKontron Instruments, Inc.1985-03-271130
K843355TRANSDUCER FOR KONTROL 5MHZ SIGMA 20Kontron Instruments, Inc.1984-12-03980
K833680SIGMA 20 ELECTRONIC SECTOR SCANNERKontron Instruments, Inc.1984-02-171190
K831733TEMPERATURE MODULE 242-100Kontron Instruments, Inc.1983-08-24850
K822584MULTI-PRONG FETAL SCALP ELECTRODEKontron Instruments, Inc.1983-02-241820

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