Cleared Traditional

K882551 - AMBULATORY PH DATA RECORDER SYSTEM

K882551 is an FDA 510(k) clearance for AMBULATORY PH DATA RECORDER SYSTEM, manufactured by Intl. Biomedics, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code KLA cleared through the Traditional 510(k) pathway after a 113-day FDA review.

K882551 · Intl. Biomedics, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1988
Decision
113d
Days
Class 2
Risk

K882551 is an FDA 510(k) clearance for the AMBULATORY PH DATA RECORDER SYSTEM, APH-2000. Classified as Monitor, Esophageal Motility, Anorectal Motility, And Tube (product code KLA), Class II - Special Controls.

Submitted by Intl. Biomedics, Inc. (Houston, US). The FDA issued a Cleared decision on October 12, 1988 after a review of 113 days - within the typical 510(k) review window.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.1725 - the FDA gastroenterology and urology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Gastroenterology & Urology review framework, consistent with the majority of Class II 510(k) submissions.

View all Intl. Biomedics, Inc. devices

FDA 510(k) Submission Details - K882551

510(k) Number K882551 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 21, 1988
Decision Date October 12, 1988
Days to Decision 113 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
17d faster than avg
Panel avg: 130d · This submission: 113d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KLA Device Classification - Class 2, Special Controls

Product Code KLA Monitor, Esophageal Motility, Anorectal Motility, And Tube
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.1725
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Gastroenterology & Urology devices follow this clearance model.

Regulatory Peers - KLA Monitor, Esophageal Motility, Anorectal Motility, And Tube

All 9
Devices cleared under the same product code (KLA) and FDA review panel - the closest regulatory comparables to K882551.
MEDTRONIC SINGLE USE ESOPHAGEAL MANOMETRIC CATHETER, MEDTRONIC SINGLE USE ANORECTAL MANOMETRIC CATHETER
K032138 · Medtronic Vascular · Oct 2003
PROVOCATIVE SENSITIVITY BALLOON
K901125 · Wilson-Cook Medical, Inc. · Jan 1991
WILSON-COOK ESOPHAGEAL MOTILITY CATHETER
K900239 · Wilson-Cook Medical, Inc. · Jul 1990
PRESSURE MONITOR MANOMETRIC SYS.
K771265 · Physio-Control Corp. · Nov 1977
HILL TUBE
K771723 · Physio-Control Corp. · Nov 1977