JAF · Class II · 21 CFR 892.1540

FDA Product Code JAF: Monitor, Ultrasonic, Nonfetal

Leading manufacturers include Thd Spa, Imex Medical Systems, Inc. and Kt Medical, 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 Dec 24, 2009
LIFEDOP MODEL 300ABI
K093393
Summit Doppler Systems, Inc.
Radiology · 55d
Cleared Jan 28, 2009
THD SLIDE ONE
K090009
Thd Spa
Radiology · 26d
Cleared Jul 30, 2008
THD SLIDE
K081429
Thd Spa
Radiology · 70d
Cleared Jun 20, 2007
THD
K070815
G.F. S.R.L.
Radiology · 86d
Cleared Dec 19, 2006
VISTA AVS
K063600
Summit Doppler Systems, Inc.
Radiology · 15d
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 Mar 09, 2001
NICOLET VERSALAB
K010521
Nicolet Biomedical
Radiology · 15d
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 Nov 21, 1995
FLOSCOPE SUPER VASCULAR LAB
K943200
Advance Medical Device, Inc.
Radiology · 504d
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 Jun 18, 1992
ULTRA PVD
K912925
Advanced Medical Products, Inc.
Radiology · 351d
Cleared Oct 15, 1991
ULTRASOUND STETHOSCOPE(R) INTRADOP(R)
K912033
Medadonics, Inc.
Radiology · 159d
Cleared Apr 29, 1991
MULTILAB 2000
K904392
Unetixs, Inc.
Radiology · 217d
Cleared Aug 22, 1990
MULTI DOPPLEX, MD-1
K900882
Huntleigh Technology, Inc.
Radiology · 177d

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 →