Cleared Traditional

K912165 - LANDMARK DUAL-LUMEN MIDLINE CATHETER SY...

K912165 is the FDA 510(k) clearance for LANDMARK DUAL-LUMEN MIDLINE CATHETER SY... by Menlo Care, Inc.. It is a Class 2 General Hospital device (product code FOZ) cleared through the Traditional 510(k) pathway after a 209-day FDA review.

K912165 · Menlo Care, Inc. · General Hospital
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Dec 1991
Decision
209d
Days
Class 2
Risk

K912165 is an FDA 510(k) clearance for the LANDMARK DUAL-LUMEN MIDLINE CATHETER SYSTEM. Classified as Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days (product code FOZ), Class II - Special Controls.

Submitted by Menlo Care, Inc. (Menlo Park, US). The FDA issued a Cleared decision on December 11, 1991 after a review of 209 days - an extended review cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5200 - the FDA general hospital 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 General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all Menlo Care, Inc. devices

Submission Details

510(k) Number K912165 FDA.gov
FDA Decision Cleared Substantially Equivalent - De Novo Granted (SEKD)
Date Received May 16, 1991
Decision Date December 11, 1991
Days to Decision 209 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
80d slower than avg
Panel avg: 129d · This submission: 209d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code FOZ Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5200
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 General Hospital devices follow this clearance model.

Regulatory Peers - FOZ Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days

All 265
Devices cleared under the same product code (FOZ) and FDA review panel - the closest regulatory comparables to K912165.
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K920128 · Menlo Care, Inc. · Mar 1992
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K920133 · Menlo Care, Inc. · Mar 1992
LANDMARK ADD-A-LUMEN CATHETER KIT
K912358 · Menlo Care, Inc. · Jan 1992
VERSACATH(TM) SELECTALUMEN(TM) W/CONVERSION TRAY
K910565 · Menlo Care, Inc. · Jun 1991
VERSACATH(TM) MULTILUMEN SYSTEM
K910566 · Menlo Care, Inc. · Jun 1991
VERSACATH(TM0 MAINLINE(TM) WITH INTRODUCTION TRAY
K910564 · Menlo Care, Inc. · May 1991