Cleared Traditional

K881478 - MODIFIED KEYMED FLEXIBLE ESOPHAGEAL DILATORS (FDA 510(k) Clearance)

Class II Gastroenterology & Urology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K881478 · Keymed (Medical & Industrial Equipment), Ltd. · Gastroenterology & Urology device
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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

Submission Details

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.

Device Classification

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.