Product Code: JOM FDA class 2 21 CFR 870.2780

Plethysmograph, Photoelectric, Pneumatic Or Hydraulic

Cardiovascular

The Plethysmograph, Photoelectric, Pneumatic or Hydraulic is a cardiovascular diagnostic instrument used to measure changes in blood volume or blood flow in peripheral vessels and limbs using photoelectric, pneumatic, or hydraulic sensing technologies, supporting assessment of peripheral vascular disease and circulatory disorders. This device is FDA Class 2, indicating moderate risk and requiring 510(k) premarket notification prior to marketing. It carries product code JOM and is regulated under 21 CFR 870.2780, within the Cardiovascular medical specialty. This device is eligible for third-party 510(k) review.

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FEI Numbers

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Basic Information

Product Code: JOM
Device Class: FDA class 2
Regulation Number: 870.2780
Medical Specialty: Cardiovascular
Review Panel: CV
Submission Type: 1

Device Characteristics

✗

GMP Exempt

✗

Implant

✗

Life Sustain/Support

✓

Third Party

—

Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 53 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K220527	PADnet Xpress	Oct 20, 2022	Substantially Equivalent	Collaborative Care Diagnostics, LLC, D.B.A. Biomedix
K213730	MESI mTABLET TBI diagnostic system, MESI mTABLET TBI	Apr 21, 2022	Substantially Equivalent	Mesi, Development of Medical Devices, Ltd.; Mesi D.O.O.
K200567	ASI Plethysmogrpah Analyzer	Feb 26, 2021	Substantially Equivalent	Arterial Stiffness, Inc.
K201046	Automated ankle brachial pressure index measuring device, MESI mTABLET system	Dec 11, 2020	Substantially Equivalent	Mesi D.O.O.; Mesi, Development of Medical Devices, Ltd.
K191266	VitalScan ANS	Jan 15, 2020	Substantially Equivalent	Medeia, Inc.
K172655	Automated ankle brachial pressure index measuring device	Jan 11, 2018	Substantially Equivalent	Mesi D.O.O.; Mesi, Development of Medical Devices, Ltd.
K173696	TBL-ABI System	Dec 19, 2017	Substantially Equivalent	Ld Technology, LLC
K143152	TM-ABI system	Jul 22, 2015	Substantially Equivalent	Ld Technology, LLC
K143094	QuantaFlo	Mar 05, 2015	Substantially Equivalent	Semler Scientific, Inc.
K123921	BODYTRONIC 200	Apr 26, 2013	Substantially Equivalent	Bauerfeind AG
K121108	DOPPLEX ABILITY	Jan 03, 2013	Substantially Equivalent	Huntleigh Healthcare
K122281	PADNET 2.0	Aug 29, 2012	Substantially Equivalent	Biomedix, Inc.
K110374	MAX PULSE SYSTEM	Jun 13, 2011	Substantially Equivalent	Medicore Co., Ltd.
K101983	CRITICAL CARE ASSESSMENT	Sep 21, 2010	Substantially Equivalent	Critical Patient Care, Inc.
K093192	FLOCHEC PHOTO PLETHYSMOGRAPHIC DEVICE	Feb 12, 2010	Substantially Equivalent	Advanced Vascular Dynamics
K083735	ANSHA AUTONOMIC NERVOUS SYSTEM HEALTH ASSESSMENT PLUS	Feb 18, 2009	Substantially Equivalent	Medtechs, LLC
K073323	SA-3000P	Nov 29, 2007	Substantially Equivalent	Medicore Co., Ltd.
K073146	PADNET+	Nov 21, 2007	Substantially Equivalent	Biomedix, Inc.
K042616	BIOMEDIX PADNET LAB	Oct 12, 2004	Substantially Equivalent	Biomedix, Inc.
K023238	MCPULSE	Feb 19, 2003	Substantially Equivalent	Meridian Co., Ltd.
K023707	A16 BLOOD FLOW MEASUREMENT SYSTEM	Feb 12, 2003	Substantially Equivalent	D. E. Hokanson, Inc.
K022047	PHLEBOTEST 2000	Nov 04, 2002	Substantially Equivalent	Osborn Medical Corp.
K990123	PVR-100/VASOGRAM	Apr 12, 1999	Substantially Equivalent	Vasocor, Inc.
K983900	VENOMETER	Jan 29, 1999	Substantially Equivalent	Advanced Medical Technology , Ltd.
K982707	EC6 PLETHYSMOGRAPH	Aug 26, 1998	Substantially Equivalent	D. E. Hokanson, Inc.
K973659	VASOCOR PVR 100	Dec 17, 1997	Substantially Equivalent	Vasocor, Inc.
K944395	ELCAT D-PPG, PLETHYSMOGRAPH DEVICE	May 10, 1995	Substantially Equivalent	Dermatology Assoc.
K905114	A.P.GRAPH III(TM) CARDIOVASCULAR ANALYZER	May 07, 1991	Substantially Equivalent	Research Consultants, Inc.
K896500	CWD/PPG MODULE	Jul 18, 1990	Substantially Equivalent	Life Sciences Manufacturing, Inc.
K884624	MVL/MODULAB WITH PVR MODULE	Feb 01, 1989	Substantially Equivalent	Life Sciences Manufacturing, Inc.
K884451	DOPCORD PPG	Jan 12, 1989	Substantially Equivalent	Huntleigh Technology, Inc.
K882547	VARITEST	Nov 03, 1988	Substantially Equivalent	Eureka AB
K883908	3D VASCULAR RECORDER	Oct 28, 1988	Substantially Equivalent	D. E. Hokanson, Inc.
K875118	PERIPHERAL VASCULAR LABORATORY ASSISTANT MODEL 101	May 16, 1988	Substantially Equivalent	Bloodflow Laboratory, Inc.
K872517	TL 400 TOTALAB VASCULAR DIAGNOSTIC SYSTEM	Oct 01, 1987	Substantially Equivalent	D. E. Hokanson, Inc.
K863702	PULSE CUFF RECORDER MODEL PCR100	Jun 12, 1987	Substantially Equivalent	Imex Medical Systems, Inc.
K863803	VASOPULSE(TM)/MODEL 5000	May 06, 1987	Substantially Equivalent	Sonicaid, Inc.
K853331	OSM-1 OXYGEN SATURATION MONITOR	Jan 14, 1986	Substantially Equivalent	Criticare Systems, Inc.
K853124	NOVAMETRIX PULSE OXIMETER, MODEL 500	Nov 06, 1985	Substantially Equivalent	Novametrix Medical Systems, Inc.
K851128	DIGITMATIC DM2	Jul 19, 1985	Substantially Equivalent	Medimatic
K833561	LIGHT REFLECTION RHEOGRAPHY	Jan 08, 1985	Substantially Equivalent	Instru-Med, Inc.
K832374	PHOTOFLO DUAL-MODE PHOTOPLETHYSMOGRAPH	Dec 01, 1983	Substantially Equivalent	Sonicaid, Inc.
K832528	MGI STRENGTH/FITNESS SYS-MODEL #PU-101	Oct 20, 1983	Substantially Equivalent	Mgi Strength/Fitness Systems, Inc.
K831955	HR 100T	Aug 11, 1983	Substantially Equivalent	Thought Technology , Ltd.
K812609	VASCULAB #VSC21	Oct 02, 1981	Substantially Equivalent	Medasonics, Inc.
K801291	EC-4 PLETHYSMOGRAPH	Jul 08, 1980	Substantially Equivalent	D. E. Hokanson, Inc.
K791927	HEART RATE COMPUTER STRIP CHART	Nov 13, 1979	Substantially Equivalent	Stanford Assoc., Inc.
K790999	APOLLO HEART RATE INDICATOR	Jun 22, 1979	Substantially Equivalent	Apollo Products, Inc.
K790450	NOVATEC PRM	Apr 06, 1979	Substantially Equivalent	Novatec, Inc.
K782132	PLETHYSMOGRAPH, STRAIN GAUGE	Feb 26, 1979	Substantially Equivalent	Medasonics, Inc.
K780761	ELECTRO-PLETHYSMOGRAPH	Jun 30, 1978	Substantially Equivalent	Biotecx Laboratories, Inc.
K770332	AMPLIFIER, PHOTOPULSE, MODEL PA13	Feb 24, 1977	Substantially Equivalent	Medsonics
K760504	PLETHYSMOGRAPH (MDI SYSTEM II)	Aug 26, 1976	Substantially Equivalent	Marketing Development Intl.