Cleared Traditional

K951620 - MIDMARK MIDLINE CATHETER

K951620 is an FDA 510(k) clearance for MIDMARK MIDLINE CATHETER, 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 363-day FDA review.

K951620 · Menlo Care, Inc. · General Hospital
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Apr 1996
Decision
363d
Days
Class 2
Risk

K951620 is an FDA 510(k) clearance for the MIDMARK MIDLINE CATHETER. 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 April 4, 1996 after a review of 363 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 - K951620

510(k) Number K951620 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 07, 1995
Decision Date April 04, 1996
Days to Decision 363 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
234d slower than avg
Panel avg: 129d · This submission: 363d
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 K951620.
MEDCOMP P-CATH
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K960051 · Nissho Corp. · Mar 1996
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K955839 · Baxter Edwards · Mar 1996