Atlas FDA

KLA

31 FDA 510(k) clearances · Product code

172 daysmedian time to decision
319 days90th percentile
31clearances measured

FDA profile

Official device name
Monitor, Esophageal Motility, Anorectal Motility, And Tube
Device class
Class II (moderate risk)
Regulation
21 CFR 876.1725
Medical specialty
Gastroenterology, Urology
Flags
Third-party review eligible
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RecordFirmDate
Fecobionics Anorectal System (K242666)Gi Bionics, LLC2025-02-12
RED (K242304)Neuraxis, Inc.2024-12-06
Solar™ Anorectal Manometry Catheter (Model Number: K1210AC-L-2212) (K234107)Laborie Medical Technologies, Corp.2024-04-23
THD Anopress with THD SensyProbe (K180135)Thd Spa2018-03-08
THD ANOPRESS (K161785)Thd Spa2017-03-14
mcompass Biofeedback Anorectal Manometry System (K143031)Medspira, LLC2015-07-07
MCOMPASS ANORECTAL MANOMETRY SYSTEM (K120088)Medspira, LLC2012-03-29
SINGLE USE ESOPHAGEAL MANOMETEY CATHETERS AND SINGLE USE ANO-RECTAL MANOMETRY CATHETERS (K062362)Sarmed Srl2007-04-13
MEDIPLUS SINGLE USE LOWER GI MANOMETRY CATHETER (K031617)Mediplus , Ltd.2004-01-16
MEDTRONIC SINGLE USE ESOPHAGEAL MANOMETRIC CATHETER, MEDTRONIC SINGLE USE ANORECTAL MANOMETRIC CATHETER (K032138)Medtronic Vascular2003-10-09
COMPASS ESOPHAGEAL PRESSURE CATHETER, MODEL GIE-8500, COMPASS ANO-RECTAL PRESSURE CATHETER, MODEL GIA-8500 (K022023)Clinical Innovations, Inc.2003-01-07
MEDIPLUS SINGLE USE GI MANOMETRY CATHETER (K013704)Mediplus , Ltd.2002-08-05
MANOMETRIC ASSEMBLIES (K983665)Dentsleeve Pty., Ltd.1999-05-17
FLEXILOG LS (K964804)Oakfield Instruments, Ltd.1997-08-06
FLEXILOG 3000 (K964589)Oakfield Instruments, Ltd.1997-03-04
FLEXILOG LS 13921 (K961895)Oakfield Instruments, Ltd.1996-11-04
ESOPHAGEAL MANOMETRY ANALYSIS MODULE (K961070)Synectics Medical, Inc.1996-06-11
BIOVIEW MODEL S960000 (K961056)Sandhill Scientific, Inc.1996-06-06
7100 SWALLOWING WORKSTATION (K954798)Kay Elemetrics Corp.1996-06-04
ANALGRAPH (K941801)Sandhill Scientific, Inc.1995-09-08
CLA-COMPUTERIZED LARYNGEAL ANALYZER (K922553)H.I.L. Research, Ltd.1994-08-23
MONOCRYSTANT PH/LES CATHETER, MODIFICATION (K914793)Synectics-Dantec1993-12-13
PROVOCATIVE SENSITIVITY BALLOON (K901125)Wilson-Cook Medical, Inc.1991-01-25
WILSON-COOK ESOPHAGEAL MOTILITY CATHETER (K900239)Wilson-Cook Medical, Inc.1990-07-16
ZINETICS(R) EMC (K884527)Zinetics Medical, Inc.1989-02-28
AMBULATORY PH DATA RECORDER SYSTEM, APH-2000 (K882551)Intl. Biomedics, Inc.1988-10-12
PC POLYGRAF (K872712)Synectics-Dantec1988-03-18
SANDHILL DMS (K821588)Sandhill1982-06-22
HILL TUBE (K771723)Physio-Control Corp.1977-11-22
PRESSURE MONITOR MANOMETRIC SYS. (K771265)Physio-Control Corp.1977-11-22
MONITOR, RESPIRATORY, TWO-GAS, RDC (K770785)Research Development Corp.1977-05-20

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