Cleared Traditional

K896774 - STREAMLINE VASCULAR ACCESS DEVICE

K896774 is an FDA 510(k) clearance for STREAMLINE VASCULAR ACCESS DEVICE, 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 26-day FDA review.

K896774 · Menlo Care, Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 1989
Decision
26d
Days
Class 2
Risk

K896774 is an FDA 510(k) clearance for the STREAMLINE VASCULAR ACCESS DEVICE. Classified as Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days (product code FOZ), Class II - Special Controls.

Submitted by Menlo Care, Inc. (Palo Alto, US). The FDA issued a Cleared decision on December 27, 1989 after a review of 26 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 - K896774

510(k) Number K896774 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 01, 1989
Decision Date December 27, 1989
Days to Decision 26 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
103d faster than avg
Panel avg: 129d · This submission: 26d
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 K896774.
DESERET OPTIMA INTRAVASCULAR CATHETER
K900116 · Deseret Medical, Inc. · Jun 1990
DESERET INTRAVASCULAR CATHETER
K895734 · Deseret Medical, Inc. · Apr 1990
EXEL SAFELET CATHETER
K895768 · Exel Intl. · Feb 1990
OPTICALLY CLEAR RADIOPAQUE CATHETER
K893546 · Critikon Company, LLC · Nov 1989
PROLONG INTRAVASCULAR CATHETER
K893965 · Baxter Healthcare Corp · Sep 1989
PROCEDURE READY TRAYS
K884577 · Professional Medical Services · Aug 1989