Product Code: KLA FDA class 2 21 CFR 876.1725

Monitor, Esophageal Motility, Anorectal Motility, And Tube

Gastroenterology, Urology

The Esophageal Motility and Anorectal Motility Monitor, with associated tube, is a diagnostic device used to measure and record the pressure and motility patterns of the esophagus and anorectal region, aiding in the diagnosis of motility disorders such as achalasia, dysphagia, and fecal incontinence. It is classified as FDA Class 2, indicating moderate risk requiring 510(k) premarket clearance. The product code is KLA and it is regulated under 21 CFR 876.1725 in the Gastroenterology and Urology specialty. This device is eligible for third-party review.

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510(k)s

FEI Numbers

Registration Numbers

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Basic Information

Product Code: KLA
Device Class: FDA class 2
Regulation Number: 876.1725
Medical Specialty: Gastroenterology, Urology
Review Panel: GU
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 31 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K242666	Fecobionics Anorectal System	Feb 12, 2025	Substantially Equivalent	Gi Bionics, LLC
K242304	RED	Dec 06, 2024	Substantially Equivalent	Neuraxis, Inc.
K234107	Solar Anorectal Manometry Catheter (Model Number: K1210AC-L-2212)	Apr 23, 2024	Substantially Equivalent	Laborie Medical Technologies, Corp.
K180135	THD Anopress with THD SensyProbe	Mar 08, 2018	Substantially Equivalent	Thd Spa
K161785	THD ANOPRESS	Mar 14, 2017	Substantially Equivalent	Thd Spa
K143031	mcompass Biofeedback Anorectal Manometry System	Jul 07, 2015	Substantially Equivalent	Medspira, LLC
K120088	MCOMPASS ANORECTAL MANOMETRY SYSTEM	Mar 29, 2012	Substantially Equivalent	Medspira, LLC
K062362	SINGLE USE ESOPHAGEAL MANOMETEY CATHETERS AND SINGLE USE ANO-RECTAL MANOMETRY CATHETERS	Apr 13, 2007	Substantially Equivalent	Sarmed Srl
K031617	MEDIPLUS SINGLE USE LOWER GI MANOMETRY CATHETER	Jan 16, 2004	Substantially Equivalent	Mediplus , Ltd.
K032138	MEDTRONIC SINGLE USE ESOPHAGEAL MANOMETRIC CATHETER, MEDTRONIC SINGLE USE ANORECTAL MANOMETRIC CATHETER	Oct 09, 2003	Substantially Equivalent	Medtronic Vascular
K022023	COMPASS ESOPHAGEAL PRESSURE CATHETER, MODEL GIE-8500, COMPASS ANO-RECTAL PRESSURE CATHETER, MODEL GIA-8500	Jan 07, 2003	Substantially Equivalent	Clinical Innovations, Inc.
K013704	MEDIPLUS SINGLE USE GI MANOMETRY CATHETER	Aug 05, 2002	Substantially Equivalent	Mediplus , Ltd.
K983665	MANOMETRIC ASSEMBLIES	May 17, 1999	Substantially Equivalent	Dentsleeve Pty., Ltd.
K964804	FLEXILOG LS	Aug 06, 1997	Substantially Equivalent	Oakfield Instruments, Ltd.
K964589	FLEXILOG 3000	Mar 04, 1997	Substantially Equivalent	Oakfield Instruments, Ltd.
K961895	FLEXILOG LS 13921	Nov 04, 1996	Substantially Equivalent	Oakfield Instruments, Ltd.
K961070	ESOPHAGEAL MANOMETRY ANALYSIS MODULE	Jun 11, 1996	Substantially Equivalent	Synectics Medical, Inc.
K961056	BIOVIEW MODEL S960000	Jun 06, 1996	Substantially Equivalent	Sandhill Scientific, Inc.
K954798	7100 SWALLOWING WORKSTATION	Jun 04, 1996	Substantially Equivalent	Kay Elemetrics Corp.
K941801	ANALGRAPH	Sep 08, 1995	Substantially Equivalent	Sandhill Scientific, Inc.
K922553	CLA-COMPUTERIZED LARYNGEAL ANALYZER	Aug 23, 1994	Substantially Equivalent	H.I.L. Research, Ltd.
K914793	MONOCRYSTANT PH/LES CATHETER, MODIFICATION	Dec 13, 1993	Substantially Equivalent	Synectics-Dantec
K901125	PROVOCATIVE SENSITIVITY BALLOON	Jan 25, 1991	Substantially Equivalent	Wilson-Cook Medical, Inc.
K900239	WILSON-COOK ESOPHAGEAL MOTILITY CATHETER	Jul 16, 1990	Substantially Equivalent	Wilson-Cook Medical, Inc.
K884527	ZINETICS(R) EMC	Feb 28, 1989	Substantially Equivalent	Zinetics Medical, Inc.
K882551	AMBULATORY PH DATA RECORDER SYSTEM, APH-2000	Oct 12, 1988	Substantially Equivalent	Intl. Biomedics, Inc.
K872712	PC POLYGRAF	Mar 18, 1988	Substantially Equivalent	Synectics-Dantec
K821588	SANDHILL DMS	Jun 22, 1982	Substantially Equivalent	Sandhill
K771723	HILL TUBE	Nov 22, 1977	Substantially Equivalent	Physio-Control Corp.
K771265	PRESSURE MONITOR MANOMETRIC SYS.	Nov 22, 1977	Substantially Equivalent	Physio-Control Corp.
K770785	MONITOR, RESPIRATORY, TWO-GAS, RDC	May 20, 1977	Substantially Equivalent	Research Development Corp.