Product code KLA— Gastroenterology, Urology
7100 SWALLOWING WORKSTATION
- Classification name
- Monitor, Esophageal Motility, Anorectal Motility, And Tube
- Device class
- Class 2
- Regulation
- 21 CFR 876.1725
- Advisory panel
- Gastroenterology, Urology
- Total cleared
- 31
- First cleared
- Most recent
Market context for product code KLA
FDA has cleared devices under product code KLA between 1977 and 2025, filed by 22 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Clearances per year
last 15 years- 2025
- 2024
- 2018
- 2017
- 2015
- 2012
- 2007
- 2004
- 2003
- 2002
- 1999
- 1997
- 1996
- 1995
- 1994
Top applicants under product code KLA
Recent clearances under product code KLA
- K242666 — Fecobionics Anorectal System
- K242304 — RED
- K234107 — Solar Anorectal Manometry Catheter (Model Number: K1210AC-L-2212)
- K180135 — THD Anopress with THD SensyProbe
- K161785 — THD ANOPRESS
- K143031 — mcompass Biofeedback Anorectal Manometry System
- K120088 — MCOMPASS ANORECTAL MANOMETRY SYSTEM
- K062362 — SINGLE USE ESOPHAGEAL MANOMETEY CATHETERS AND SINGLE USE ANO-RECTAL MANOMETRY CATHETERS
- K031617 — MEDIPLUS SINGLE USE LOWER GI MANOMETRY CATHETER
- K032138 — MEDTRONIC SINGLE USE ESOPHAGEAL MANOMETRIC CATHETER, MEDTRONIC SINGLE USE ANORECTAL MANOMETRIC CATHETER
- K022023 — COMPASS ESOPHAGEAL PRESSURE CATHETER, MODEL GIE-8500, COMPASS ANO-RECTAL PRESSURE CATHETER, MODEL GIA-8500
- K013704 — MEDIPLUS SINGLE USE GI MANOMETRY CATHETER
- K983665 — MANOMETRIC ASSEMBLIES
- K964804 — FLEXILOG LS
- K964589 — FLEXILOG 3000
- K961895 — FLEXILOG LS 13921
- K961070 — ESOPHAGEAL MANOMETRY ANALYSIS MODULE
- K961056 — BIOVIEW MODEL S960000
- K954798 — 7100 SWALLOWING WORKSTATION
- K941801 — ANALGRAPH
- K922553 — CLA-COMPUTERIZED LARYNGEAL ANALYZER
- K914793 — MONOCRYSTANT PH/LES CATHETER, MODIFICATION
- K901125 — PROVOCATIVE SENSITIVITY BALLOON
- K900239 — WILSON-COOK ESOPHAGEAL MOTILITY CATHETER
- K884527 — ZINETICS(R) EMC
- K882551 — AMBULATORY PH DATA RECORDER SYSTEM, APH-2000
- K872712 — PC POLYGRAF
- K821588 — SANDHILL DMS
- K771265 — PRESSURE MONITOR MANOMETRIC SYS.
- K771723 — HILL TUBE
- K770785 — MONITOR, RESPIRATORY, TWO-GAS, RDC
Data sourced from openFDA. This site is unofficial and independent of the FDA.