JOM · Class II · 21 CFR 870.2780

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

Leading manufacturers include Mesi D.O.O.; Mesi, Development of Medical Devices, Ltd., Arterial Stiffness, Inc. and Mesi, Development of Medical Devices, Ltd.; Mesi D.O.O..

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

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.