Cleared Traditional

K912919 - MENTOR INFUSION LINE

K912919 is an FDA 510(k) clearance for MENTOR INFUSION LINE, manufactured by Mentor Corp.. The device is a Class 2 Gastroenterology & Urology device with product code KNY cleared through the Traditional 510(k) pathway after a 163-day FDA review.

K912919 · Mentor Corp. · Gastroenterology & Urology device
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Dec 1991
Decision
163d
Days
Class 2
Risk

K912919 is an FDA 510(k) clearance for the MENTOR INFUSION LINE. Classified as Accessories, Catheter, G-u (product code KNY), Class II - Special Controls.

Submitted by Mentor Corp. (Goleta, US). The FDA issued a Cleared decision on December 13, 1991 after a review of 163 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 Mentor Corp. devices

FDA 510(k) Submission Details - K912919

510(k) Number K912919 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 03, 1991
Decision Date December 13, 1991
Days to Decision 163 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
32d slower than avg
Panel avg: 131d · This submission: 163d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KNY Device Classification - Class 2, Special Controls

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 45
Devices cleared under the same product code (KNY) and FDA review panel - the closest regulatory comparables to K912919.
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MODIFIED PEDIATRIC SILICONE FOLEY CATHETERS
K900031 · Porges Corp. · Mar 1990
CATHETER PLUG/PROTECTOR
K896806 · Westmark, Sterile Packing Systems, Inc. (Sps) · Feb 1990