Cleared Traditional

K881478 - MODIFIED KEYMED FLEXIBLE ESOPHAGEAL DIL...

K881478 is an FDA 510(k) clearance for MODIFIED KEYMED FLEXIBLE ESOPHAGEAL DIL..., manufactured by Keymed (Medical & Industrial Equipment), Ltd.. The device is a Class 2 Gastroenterology & Urology device with product code KNQ cleared through the Traditional 510(k) pathway after a 161-day FDA review.

K881478 · Keymed (Medical & Industrial Equipment), Ltd. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 1988
Decision
161d
Days
Class 2
Risk

K881478 is an FDA 510(k) clearance for the MODIFIED KEYMED FLEXIBLE ESOPHAGEAL DILATORS. Classified as Dilator, Esophageal (product code KNQ), Class II - Special Controls.

Submitted by Keymed (Medical & Industrial Equipment), Ltd. (Essex, GB). The FDA issued a Cleared decision on September 14, 1988 after a review of 161 days - an extended review cycle.

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. 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 Keymed (Medical & Industrial Equipment), Ltd. devices

FDA 510(k) Submission Details - K881478

510(k) Number K881478 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 06, 1988
Decision Date September 14, 1988
Days to Decision 161 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
31d slower than avg
Panel avg: 130d · This submission: 161d
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 22
Devices cleared under the same product code (KNQ) and FDA review panel - the closest regulatory comparables to K881478.
MICROVASIVE MAXFORCE
K934697 · Boston Scientific Corp · May 1994
OLYMPUS SCLEROTHERAPY BALLOON
K933992 · Olympus Corp. · Dec 1993
WILSON-COOK BALLOON DILATION CATHETERS
K900924 · Wilson-Cook Medical, Inc. · Dec 1990
KEYMED FLEXIBLE ESOPHAGEAL DILATORS
K862000 · Keymed, Inc. · Aug 1986
SAVARY-GILLIARD DILATOR
K851955 · Wilson-Cook Medical, Inc. · Jul 1985
ESOPHAGEAL BOUGIES
K830991 · Medovations, Inc. · Jun 1983