Cleared Traditional

K930048 - SAFE-PICC CATHETER

K930048 is an FDA 510(k) clearance for SAFE-PICC 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 492-day FDA review.

K930048 · Menlo Care, Inc. · General Hospital
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May 1994
Decision
492d
Days
Class 2
Risk

K930048 is an FDA 510(k) clearance for the SAFE-PICC 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 May 12, 1994 after a review of 492 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind General Hospital submissions.

View all Menlo Care, Inc. devices

FDA 510(k) Submission Details - K930048

510(k) Number K930048 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 05, 1993
Decision Date May 12, 1994
Days to Decision 492 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
363d slower than avg
Panel avg: 129d · This submission: 492d
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 K930048.
CUFF-CATH
K935090 · Ohmeda Medical · Oct 1994
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K940634 · Micro Therapeutics, Inc. · Oct 1994
VITAFLON PLUS/VASCULON
K941417 · Hogan & Hartson · Oct 1994
CATH-FINDER
K931073 · Pharmacia Deltec, Inc. · May 1994
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K926544 · Pharmacia Deltec, Inc. · Mar 1994
PICC INSERTION TRAY
K931668 · Clinipad Corp. · Mar 1994