JAF · Class II · 21 CFR 892.1540

FDA Product Code JAF: Monitor, Ultrasonic, Nonfetal

Leading manufacturers include Imex Medical Systems, Inc., Philips Medical Systems, Inc. and Biomedix, Inc..

38
Total
38
Cleared
140d
Avg days
1978
Since
Growing category - 1 submissions in the last 2 years vs 0 in the prior period
Review times improving: avg 114d recently vs 141d historically

FDA 510(k) Cleared Monitor, Ultrasonic, Nonfetal Devices (Product Code JAF)

38 devices
1–24 of 38
Cleared Dec 13, 2024
Laminar P1 (LDH-HW-001)
K242487
Laminar Digital Health, Inc.
Cardiovascular · 114d
Cleared Feb 24, 2015
THD REVOLUTION
K141657
Thd Spa
Radiology · 249d
Cleared May 12, 2011
SIMPLEABI
K110628
Newman Medical
Radiology · 70d
Cleared Apr 10, 2006
STETHOFLUX
K060064
Odvi
Radiology · 91d
Cleared Aug 29, 2005
DOPPLER GUIDED PROCTOSCOPE, MODEL 500H
K052067
Multigon Industries, Inc.
Radiology · 28d
Cleared Aug 07, 1998
CAREDOP II
K982635
Nicolet Biomedical
Radiology · 25d
Cleared Feb 05, 1998
IMEX STETHODOP
K973336
Imex Medical Systems, Inc.
Radiology · 154d
Cleared Dec 29, 1997
FLOSTAT VASCULAR REPORT GENERATOR (VRG)
K973857
Biomedix, Inc.
Radiology · 81d
Cleared Dec 23, 1997
FLOSTAT VASCULAR LAB
K973644
Biomedix, Inc.
Radiology · 90d
Cleared Apr 12, 1996
BIOSENSOR BIDOP VASCULAR TEST SYSTEM
K943338
Biosensor Corp.
Radiology · 640d
Cleared May 12, 1995
IMWXDOP IR
K944196
Imex Medical Systems, Inc.
Radiology · 256d
Cleared Oct 21, 1994
R AND D BATTERIES
K935427
R & D Batteries, Inc.
Radiology · 345d
Cleared Aug 23, 1994
IMEXDOP CT+
K942441
Imex Medical Systems, Inc.
Radiology · 92d
Cleared Aug 22, 1990
MULTI DOPPLEX, MD-1
K900882
Huntleigh Technology, Inc.
Radiology · 177d
Cleared Sep 21, 1988
MEDACORD PVL, PERSONAL VASCULAR LABORATORY
K882018
Medasonics, Inc.
Radiology · 131d
Cleared Apr 23, 1986
HANDHELD DOPLER/PEN TRANSDUCER 3MHZ
K854590
Philips Medical Systems, Inc.
Radiology · 156d
Cleared Apr 23, 1986
SUPRASTERNAL NOTCH DOP/TRANS. 3MHZ
K854591
Philips Medical Systems, Inc.
Radiology · 156d
Cleared Nov 26, 1985
KEY MED TRANSENDOSCOPIC VASCULAR DETECTOR TVD-1
K851149
Keymed, Inc.
Radiology · 250d
Cleared Sep 19, 1985
3.5 MHZ CW DOPPLER PROBE MODEL NO. 8421802
K852572
Siemens Medical Solutions USA, Inc.
Radiology · 93d
Cleared Feb 25, 1985
EUB-40
K844128
Hitachi Medical Corp. of America
Radiology · 125d
Cleared Sep 17, 1982
HEMACOUNT WRIGHT GIEMSA STAIN PACK
K822602
Accra Laboratories, Inc.
Pathology · 21d
Cleared Jul 08, 1980
VASCULAB BI-DIRECTIONAL DOPPLER, #D10
K800768
Medasonics, Inc.
Radiology · 92d

About Product Code JAF - Regulatory Context

510(k) Submission Activity

38 total 510(k) submissions under product code JAF since 1978, with 38 receiving FDA clearance (average review time: 140 days).

Submission volume has increased in recent years - 1 submissions in the last 24 months compared to 0 in the prior period - suggesting growing market activity in this device classification.

FDA 510(k) Review Time - JAF Product Code

Recent submissions under JAF have taken an average of 114 days to reach a decision - down from 141 days historically, suggesting improved FDA processing for this classification.

JAF devices are reviewed by the Radiology panel. Browse all Radiology devices →