Cleared Traditional

K862130 - COMFORT-SET* I.V. CATHETER PLACEMENT UNIT.

K862130 is an FDA 510(k) clearance for COMFORT-SET* I.V. CATHETER PLACEMENT UNIT., 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 71-day FDA review.

K862130 · Menlo Care, Inc. · General Hospital
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Aug 1986
Decision
71d
Days
Class 2
Risk

K862130 is an FDA 510(k) clearance for the COMFORT-SET* I.V. CATHETER PLACEMENT UNIT.. 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 August 14, 1986 after a review of 71 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Menlo Care, Inc. devices

FDA 510(k) Submission Details - K862130

510(k) Number K862130 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 04, 1986
Decision Date August 14, 1986
Days to Decision 71 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
58d faster than avg
Panel avg: 129d · This submission: 71d
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 K862130.
ARROW 18GA TWO-LUMEN INTRAVENOUS CATH/23GA NEEDLE
K862153 · Arrow Intl., Inc. · Dec 1986
INTRACATH INTRAVENOUS CATHETER PLACEMENT UNIT
K861725 · Parke-Davis Co. · Dec 1986
SUPERCATH I.V. CATHETER
K864038 · Togo Medikit Co., Ltd. · Dec 1986
CAVAFIX, CENTRAL VENOUS CATHETER KIT
K861479 · Burron Medical Products, Inc. · Jul 1986
ANTHRON CATHETERS & SETS
K861117 · Toray Industries (America), Inc. · Jun 1986
MULTILUMEN VIAPIC CENTRAL LINE CATHETER
K861510 · Warner-Lambert Co. · Jun 1986