Cleared Traditional

K032127 - HEMEDEX FIXATION DEVICE

K032127 is the FDA 510(k) clearance for HEMEDEX FIXATION DEVICE by Hemedex Incorporated. It is a Class 2 Gastroenterology & Urology device (product code KNY) cleared through the Traditional 510(k) pathway after a 173-day FDA review.

K032127 · Hemedex Incorporated · Gastroenterology & Urology device
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Dec 2003
Decision
173d
Days
Class 2
Risk

K032127 is an FDA 510(k) clearance for the HEMEDEX FIXATION DEVICE. Classified as Accessories, Catheter, G-u (product code KNY), Class II - Special Controls.

Submitted by Hemedex Incorporated (Hopkonton, US). The FDA issued a Cleared decision on December 30, 2003 after a review of 173 days - an extended review cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5130 - 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 Hemedex Incorporated devices

Submission Details

510(k) Number K032127 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 10, 2003
Decision Date December 30, 2003
Days to Decision 173 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
43d slower than avg
Panel avg: 130d · This submission: 173d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code KNY Accessories, Catheter, G-u
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.5130
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 - KNY Accessories, Catheter, G-u

All 18
Devices cleared under the same product code (KNY) and FDA review panel - the closest regulatory comparables to K032127.
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K981667 · Lake Region Mfg., Inc. · Jun 1998
MANAN MANTA CATHETER FIXATION DISK
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K972977 · Cook Urological, Inc. · Oct 1997
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K960866 · Lake Region Mfg., Inc. · Apr 1996