Cleared Traditional

K954132 - MANAN MANTA CATHETER FIXATION DISK

K954132 is the FDA 510(k) clearance for MANAN MANTA CATHETER FIXATION DISK by Manan Medical Products, Inc.. It is a Class 2 Gastroenterology & Urology device (product code KNY) cleared through the Traditional 510(k) pathway after a 207-day FDA review.

K954132 · Manan Medical Products, Inc. · Gastroenterology & Urology device
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Mar 1996
Decision
207d
Days
Class 2
Risk

K954132 is an FDA 510(k) clearance for the MANAN MANTA CATHETER FIXATION DISK. Classified as Accessories, Catheter, G-u (product code KNY), Class II - Special Controls.

Submitted by Manan Medical Products, Inc. (Northbrook, US). The FDA issued a Cleared decision on March 26, 1996 after a review of 207 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 Manan Medical Products, Inc. devices

Submission Details

510(k) Number K954132 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 01, 1995
Decision Date March 26, 1996
Days to Decision 207 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
77d slower than avg
Panel avg: 130d · This submission: 207d
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 23
Devices cleared under the same product code (KNY) and FDA review panel - the closest regulatory comparables to K954132.
MANAN MANTA CATHETER FIXATION DISK
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K960866 · Lake Region Mfg., Inc. · Apr 1996
KENDALL CURITY CATHETER PLUG WITH PROTECTIVE CAP
K951488 · The Kendal Co. · Apr 1995
PRE-FILLED SYRINGE W/STERILE .25% ACETC ACID
K943835 · Orion Life Systems, Inc. · Jan 1995
AMPLATZ SUPER STIFF GUIDEWIRE
K944754 · Boston Scientific Corp · Oct 1994