Cleared Traditional

K920828 - SAFE-PICC PERIPHERALLY INSERTED CENTRAL VENOUS CAT

K920828 is an FDA 510(k) clearance for SAFE-PICC PERIPHERALLY INSERTED CENTRAL..., 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 172-day FDA review.

K920828 · Menlo Care, Inc. · General Hospital
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Aug 1992
Decision
172d
Days
Class 2
Risk

K920828 is an FDA 510(k) clearance for the SAFE-PICC PERIPHERALLY INSERTED CENTRAL VENOUS CAT. 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, 1992 after a review of 172 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 - K920828

510(k) Number K920828 FDA.gov
FDA Decision Cleared Substantially Equivalent - De Novo Granted (SEKD)
Date Received February 24, 1992
Decision Date August 14, 1992
Days to Decision 172 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
43d slower than avg
Panel avg: 129d · This submission: 172d
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 K920828.
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K920635 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Apr 1992
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K920028 · Menlo Care, Inc. · Mar 1992