JOM · Class II · 21 CFR 870.2780

FDA Product Code JOM: Plethysmograph, Photoelectric, Pneumatic Or Hydraulic

Leading manufacturers include D. E. Hokanson, Inc., Biomedix, Inc. and Medicore Co., Ltd..

53
Total
53
Cleared
121d
Avg days
1976
Since
Declining activity - 0 submissions in the last 2 years vs 1 in the prior period

FDA 510(k) Cleared Plethysmograph, Photoelectric, Pneumatic Or Hydraulic Devices (Product Code JOM)

53 devices
1–24 of 53
Cleared Oct 20, 2022
PADnet Xpress
K220527
Collaborative Care Diagnostics, LLC, D.B.A. Biomedix
Cardiovascular · 238d
Cleared Apr 21, 2022
MESI mTABLET TBI diagnostic system, MESI mTABLET TBI
K213730
Mesi, Development of Medical Devices, Ltd.; Mesi D.O.O.
Cardiovascular · 146d
Cleared Feb 26, 2021
ASI Plethysmogrpah Analyzer
K200567
Arterial Stiffness, Inc.
Cardiovascular · 359d
Cleared Dec 11, 2020
Automated ankle brachial pressure index measuring device, MESI mTABLET system
K201046
Mesi D.O.O.; Mesi, Development of Medical Devices, Ltd.
Cardiovascular · 234d
Cleared Jan 15, 2020
VitalScan ANS
K191266
Medeia, Inc.
Cardiovascular · 250d
Cleared Jan 11, 2018
Automated ankle brachial pressure index measuring device
K172655
Mesi D.O.O.; Mesi, Development of Medical Devices, Ltd.
Cardiovascular · 128d
Cleared Dec 19, 2017
TBL-ABI System
K173696
Ld Technology, LLC
Cardiovascular · 18d
Cleared Jul 22, 2015
TM-ABI system
K143152
Ld Technology, LLC
Cardiovascular · 261d
Cleared Mar 05, 2015
QuantaFlo
K143094
Semler Scientific, Inc.
Cardiovascular · 128d
Cleared Apr 26, 2013
BODYTRONIC 200
K123921
Bauerfeind AG
Cardiovascular · 127d
Cleared Jan 03, 2013
DOPPLEX ABILITY
K121108
Huntleigh Healthcare
Cardiovascular · 266d
Cleared Aug 29, 2012
PADNET 2.0
K122281
Biomedix, Inc.
Cardiovascular · 30d
Cleared Jun 13, 2011
MAX PULSE SYSTEM
K110374
Medicore Co., Ltd.
Cardiovascular · 124d
Cleared Nov 29, 2007
SA-3000P
K073323
Medicore Co., Ltd.
Cardiovascular · 2d
Cleared Nov 21, 2007
PADNET+
K073146
Biomedix, Inc.
Cardiovascular · 13d
Cleared Oct 12, 2004
BIOMEDIX PADNET LAB
K042616
Biomedix, Inc.
Cardiovascular · 19d
Cleared Feb 12, 2003
A16 BLOOD FLOW MEASUREMENT SYSTEM
K023707
D. E. Hokanson, Inc.
Cardiovascular · 100d
Cleared Apr 12, 1999
PVR-100/VASOGRAM
K990123
Vasocor, Inc.
Cardiovascular · 89d
Cleared Jan 29, 1999
VENOMETER
K983900
Advanced Medical Technology , Ltd.
Cardiovascular · 87d
Cleared Aug 26, 1998
EC6 PLETHYSMOGRAPH
K982707
D. E. Hokanson, Inc.
Cardiovascular · 23d
Cleared Dec 17, 1997
VASOCOR PVR 100
K973659
Vasocor, Inc.
Cardiovascular · 83d
Cleared Jan 12, 1989
DOPCORD PPG
K884451
Huntleigh Technology, Inc.
Cardiovascular · 80d
Cleared Oct 28, 1988
3D VASCULAR RECORDER
K883908
D. E. Hokanson, Inc.
Cardiovascular · 43d
Cleared Oct 01, 1987
TL 400 TOTALAB VASCULAR DIAGNOSTIC SYSTEM
K872517
D. E. Hokanson, Inc.
Cardiovascular · 99d

About Product Code JOM - Regulatory Context

510(k) Submission Activity

53 total 510(k) submissions under product code JOM since 1976, with 53 receiving FDA clearance (average review time: 121 days).

Submission volume has declined in recent years - 0 submissions in the last 24 months compared to 1 in the prior period.