Cleared Traditional

STREAM LINE* I.V. CATHETER PLACEMENT UNIT (K860474) - FDA 510(k) Clearance

Class II General Hospital device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K860474 · Menlo Care, Inc. · General Hospital
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May 1986
Decision
88d
Days
Class 2
Risk

K860474 is an FDA 510(k) clearance for the STREAM LINE* 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 May 6, 1986 after a review of 88 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

Submission Details

510(k) Number K860474 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 07, 1986
Decision Date May 06, 1986
Days to Decision 88 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
41d faster than avg
Panel avg: 129d · This submission: 88d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 110
Devices cleared under the same product code (FOZ) and FDA review panel - the closest regulatory comparables to K860474.
SUBCLAVIAN HEMODIALYSIS CATH. W/VITACUFF DEVICE
K884325 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Apr 1989
CENTRASIL SILICONE ELASTOMER CENTRAL VENOUS CATH
K881215 · Baxter Healthcare Corp · Jun 1988
VASCULAR ACCESS CATHETER W/ANTIMICROBIAL CUFF
K873050 · C.R. Bard, Inc. · Oct 1987
POLYCATH-H CATHETER
K854308 · Abbott Laboratories · Apr 1986
INJECTION CAP
K834480 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Feb 1984
WINGED CATHETER
K830765 · Abbott Laboratories · Mar 1983