Cleared Traditional

K921478 - GUARDPORT

K921478 is the FDA 510(k) clearance for GUARDPORT by Health Improvement Assoc.. It is a Class 2 Gastroenterology & Urology device (product code KNT) cleared through the Traditional 510(k) pathway after a 1017-day FDA review.

K921478 · Health Improvement Assoc. · Gastroenterology & Urology device
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Jan 1995
Decision
1017d
Days
Class 2
Risk

K921478 is an FDA 510(k) clearance for the GUARDPORT. Classified as Tubes, Gastrointestinal (and Accessories) (product code KNT), Class II - Special Controls.

Submitted by Health Improvement Assoc. (Freeland, US). The FDA issued a Cleared decision on January 11, 1995 after a review of 1017 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5980 - 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Gastroenterology & Urology submissions.

View all Health Improvement Assoc. devices

Submission Details

510(k) Number K921478 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 30, 1992
Decision Date January 11, 1995
Days to Decision 1017 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
887d slower than avg
Panel avg: 130d · This submission: 1017d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code KNT Tubes, Gastrointestinal (and Accessories)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.5980
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 - KNT Tubes, Gastrointestinal (and Accessories)

All 292
Devices cleared under the same product code (KNT) and FDA review panel - the closest regulatory comparables to K921478.
PERCUTANEOUS ENDOSCOPIC GASTROSTOMY
K924306 · United States Endoscopy Group, Inc. · May 1995
FLEXIFLO SIX ENTERAL NUTRITION PUMP SET
K943240 · Abbott Laboratories · Apr 1995
FLEXIFLO NASOENTERIC FEEDING TUBE
K922217 · Abbott Laboratories · Mar 1995
FLEXIFLO TUBE PLACEMENT VERIFIER
K922216 · Abbott Laboratories · Jan 1995
VANSONNENBERG GASTROSTOMY CATHETER
K924850 · Boston Scientific Corp · Dec 1994
KLEIN RECTAL TAMPNADE BALLOON
K933842 · Cook Urological, Inc. · Sep 1994