Cleared Traditional

K884712 - ESOPHAGEAL AND PYLORIC BALLOON DIALATORS

K884712 is an FDA 510(k) clearance for ESOPHAGEAL AND PYLORIC BALLOON DIALATORS, manufactured by Primrose Medical, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code KNQ cleared through the Traditional 510(k) pathway after a 304-day FDA review.

K884712 · Primrose Medical, Inc. · Gastroenterology & Urology device
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Sep 1989
Decision
304d
Days
Class 2
Risk

K884712 is an FDA 510(k) clearance for the ESOPHAGEAL AND PYLORIC BALLOON DIALATORS. Classified as Dilator, Esophageal (product code KNQ), Class II - Special Controls.

Submitted by Primrose Medical, Inc. (Woburn, US). The FDA issued a Cleared decision on September 8, 1989 after a review of 304 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5365 - 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. Elevated predicate reliance profile. 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 Primrose Medical, Inc. devices

FDA 510(k) Submission Details - K884712

510(k) Number K884712 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 08, 1988
Decision Date September 08, 1989
Days to Decision 304 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
173d slower than avg
Panel avg: 131d · This submission: 304d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KNQ Device Classification - Class 2, Special Controls

Product Code KNQ Dilator, Esophageal
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.5365
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 - KNQ Dilator, Esophageal

All 33
Devices cleared under the same product code (KNQ) and FDA review panel - the closest regulatory comparables to K884712.
OLYMPUS SCLEROTHERAPY BALLOON
K933992 · Olympus Corp. · Dec 1993
WILSON-COOK BALLOON DILATION CATHETERS
K900924 · Wilson-Cook Medical, Inc. · Dec 1990
ESOPHAGEAL BALLOON DILATOR
K901424 · Telemed Systems, Inc. · Jun 1990
PORGES STEPPED NEOPLEX DILATOR
K883526 · Porges Corp. · Oct 1988
KEYMED FLEXIBLE ESOPHAGEAL DILATORS
K862000 · Keymed, Inc. · Aug 1986
AMERICAN DILATATION SYSTEM
K853274 · American Endoscopy, Inc. · Oct 1985