Cleared Traditional

K912358 - LANDMARK ADD-A-LUMEN CATHETER KIT

K912358 is an FDA 510(k) clearance for LANDMARK ADD-A-LUMEN CATHETER KIT, manufactured by Menlo Care, Inc.. The device is a Class 2 General Hospital device with product code FOZ cleared through the Traditional 510(k) pathway after a 219-day FDA review.

K912358 · Menlo Care, Inc. · General Hospital
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Jan 1992
Decision
219d
Days
Class 2
Risk

K912358 is an FDA 510(k) clearance for the LANDMARK ADD-A-LUMEN CATHETER KIT. 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 January 2, 1992 after a review of 219 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

FDA 510(k) Submission Details - K912358

510(k) Number K912358 FDA.gov
FDA Decision Cleared Substantially Equivalent - De Novo Granted (SEKD)
Date Received May 28, 1991
Decision Date January 02, 1992
Days to Decision 219 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
90d slower than avg
Panel avg: 129d · This submission: 219d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FOZ Device Classification - Class 2, Special Controls

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 406
Devices cleared under the same product code (FOZ) and FDA review panel - the closest regulatory comparables to K912358.
LANDMARK MIDLINE CATHETER
K920028 · Menlo Care, Inc. · Mar 1992
VERSACATH MAINLINE CENTRAL VENOUS CATHETER
K920128 · Menlo Care, Inc. · Mar 1992
VERSACATH SELECTALUMEN INNER CATHETER
K920133 · Menlo Care, Inc. · Mar 1992
LANDMARK DUAL-LUMEN MIDLINE CATHETER SYSTEM
K912165 · Menlo Care, Inc. · Dec 1991
CENTRAL VENOUS CATHETER DRESSING CHANGE TRAY
K912158 · Medical Device Inspection Co., Inc. · Oct 1991
VERSACATH(TM) SELECTALUMEN(TM) W/CONVERSION TRAY
K910565 · Menlo Care, Inc. · Jun 1991