Atlas FDA

JOM

53 FDA 510(k) clearances · Product code

100 daysmedian time to decision
250 days90th percentile
53clearances measured

FDA profile

Official device name
Plethysmograph, Photoelectric, Pneumatic Or Hydraulic
Device class
Class II (moderate risk)
Regulation
21 CFR 870.2780
Medical specialty
Cardiovascular
Flags
Third-party review eligible
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RecordFirmDate
PADnet Xpress (K220527)Collaborative Care Diagnostics, LLC, D.B.A. Biomedix2022-10-20
MESI mTABLET TBI diagnostic system, MESI mTABLET TBI (K213730)Mesi, Development of Medical Devices, Ltd.; Mesi D.O.O.2022-04-21
ASI Plethysmogrpah Analyzer (K200567)Arterial Stiffness, Inc.2021-02-26
Automated ankle brachial pressure index measuring device, MESI mTABLET system (K201046)Mesi D.O.O.; Mesi, Development of Medical Devices, Ltd.2020-12-11
VitalScan ANS (K191266)Medeia, Inc.2020-01-15
Automated ankle brachial pressure index measuring device (K172655)Mesi D.O.O.; Mesi, Development of Medical Devices, Ltd.2018-01-11
TBL-ABI System (K173696)Ld Technology, LLC2017-12-19
TM-ABI system (K143152)Ld Technology, LLC2015-07-22
QuantaFlo (K143094)Semler Scientific, Inc.2015-03-05
BODYTRONIC 200 (K123921)Bauerfeind AG2013-04-26
DOPPLEX ABILITY (K121108)Huntleigh Healthcare2013-01-03
PADNET 2.0 (K122281)Biomedix, Inc.2012-08-29
MAX PULSE SYSTEM (K110374)Medicore Co., Ltd.2011-06-13
CRITICAL CARE ASSESSMENT (K101983)Critical Patient Care, Inc.2010-09-21
FLOCHEC PHOTO PLETHYSMOGRAPHIC DEVICE (K093192)Advanced Vascular Dynamics2010-02-12
ANSHA AUTONOMIC NERVOUS SYSTEM HEALTH ASSESSMENT PLUS (K083735)Medtechs, LLC2009-02-18
SA-3000P (K073323)Medicore Co., Ltd.2007-11-29
PADNET+ (K073146)Biomedix, Inc.2007-11-21
BIOMEDIX PADNET LAB (K042616)Biomedix, Inc.2004-10-12
MCPULSE (K023238)Meridian Co., Ltd.2003-02-19
A16 BLOOD FLOW MEASUREMENT SYSTEM (K023707)D. E. Hokanson, Inc.2003-02-12
PHLEBOTEST 2000 (K022047)Osborn Medical Corp.2002-11-04
PVR-100/VASOGRAM (K990123)Vasocor, Inc.1999-04-12
VENOMETER (K983900)Advanced Medical Technology , Ltd.1999-01-29
EC6 PLETHYSMOGRAPH (K982707)D. E. Hokanson, Inc.1998-08-26
VASOCOR PVR 100 (K973659)Vasocor, Inc.1997-12-17
ELCAT D-PPG, PLETHYSMOGRAPH DEVICE (K944395)Dermatology Assoc.1995-05-10
A.P.GRAPH III(TM) CARDIOVASCULAR ANALYZER (K905114)Research Consultants, Inc.1991-05-07
CWD/PPG MODULE (K896500)Life Sciences Manufacturing, Inc.1990-07-18
MVL/MODULAB WITH PVR MODULE (K884624)Life Sciences Manufacturing, Inc.1989-02-01
DOPCORD PPG (K884451)Huntleigh Technology, Inc.1989-01-12
VARITEST (K882547)Eureka AB1988-11-03
3D VASCULAR RECORDER (K883908)D. E. Hokanson, Inc.1988-10-28
PERIPHERAL VASCULAR LABORATORY ASSISTANT MODEL 101 (K875118)Bloodflow Laboratory, Inc.1988-05-16
TL 400 TOTALAB VASCULAR DIAGNOSTIC SYSTEM (K872517)D. E. Hokanson, Inc.1987-10-01
PULSE CUFF RECORDER MODEL PCR100 (K863702)Imex Medical Systems, Inc.1987-06-12
VASOPULSE(TM)/MODEL 5000 (K863803)Sonicaid, Inc.1987-05-06
OSM-1 OXYGEN SATURATION MONITOR (K853331)Criticare Systems, Inc.1986-01-14
NOVAMETRIX PULSE OXIMETER, MODEL 500 (K853124)Novametrix Medical Systems, Inc.1985-11-06
DIGITMATIC DM2 (K851128)Medimatic1985-07-19
LIGHT REFLECTION RHEOGRAPHY (K833561)Instru-Med, Inc.1985-01-08
PHOTOFLO DUAL-MODE PHOTOPLETHYSMOGRAPH (K832374)Sonicaid, Inc.1983-12-01
MGI STRENGTH/FITNESS SYS-MODEL #PU-101 (K832528)Mgi Strength/Fitness Systems, Inc.1983-10-20
HR 100T (K831955)Thought Technology , Ltd.1983-08-11
VASCULAB #VSC21 (K812609)Medasonics, Inc.1981-10-02
EC-4 PLETHYSMOGRAPH (K801291)D. E. Hokanson, Inc.1980-07-08
HEART RATE COMPUTER STRIP CHART (K791927)Stanford Assoc., Inc.1979-11-13
APOLLO HEART RATE INDICATOR (K790999)Apollo Products, Inc.1979-06-22
NOVATEC PRM (K790450)Novatec, Inc.1979-04-06
PLETHYSMOGRAPH, STRAIN GAUGE (K782132)Medasonics, Inc.1979-02-26
ELECTRO-PLETHYSMOGRAPH (K780761)Biotecx Laboratories, Inc.1978-06-30
AMPLIFIER, PHOTOPULSE, MODEL PA13 (K770332)Medsonics1977-02-24
PLETHYSMOGRAPH (MDI SYSTEM II) (K760504)Marketing Development Intl.1976-08-26

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Every clearance here is in the API, with alerts when new ones post.