Cleared Traditional

K884527 - ZINETICS EMC

K884527 is an FDA 510(k) clearance for ZINETICS EMC, manufactured by Zinetics Medical, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code KLA cleared through the Traditional 510(k) pathway after a 124-day FDA review.

K884527 · Zinetics Medical, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1989
Decision
124d
Days
Class 2
Risk

K884527 is an FDA 510(k) clearance for the ZINETICS(R) EMC. Classified as Monitor, Esophageal Motility, Anorectal Motility, And Tube (product code KLA), Class II - Special Controls.

Submitted by Zinetics Medical, Inc. (Salt Lake City, US). The FDA issued a Cleared decision on February 28, 1989 after a review of 124 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 Zinetics Medical, Inc. devices

FDA 510(k) Submission Details - K884527

510(k) Number K884527 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 27, 1988
Decision Date February 28, 1989
Days to Decision 124 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
6d faster than avg
Panel avg: 130d · This submission: 124d
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 K884527.
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