Cleared Traditional

K953746 - ARROW HIGH FLOW FLUID ADMINSITRATION SET W/BLOOD FILTER & EXTENSION SET

K953746 is an FDA 510(k) clearance for ARROW HIGH FLOW FLUID ADMINSITRATION SE..., manufactured by Arrow Intl., Inc.. The device is a Class 2 General Hospital device with product code FPA cleared through the Traditional 510(k) pathway after a 169-day FDA review.

K953746 · Arrow Intl., Inc. · General Hospital
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Jan 1996
Decision
169d
Days
Class 2
Risk

K953746 is an FDA 510(k) clearance for the ARROW HIGH FLOW FLUID ADMINSITRATION SET W/BLOOD FILTER & EXTENSION SET. Classified as Set, Administration, Intravascular (product code FPA), Class II - Special Controls.

Submitted by Arrow Intl., Inc. (Reading, US). The FDA issued a Cleared decision on January 26, 1996 after a review of 169 days - an extended review cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5440 - 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 Arrow Intl., Inc. devices

FDA 510(k) Submission Details - K953746

510(k) Number K953746 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 10, 1995
Decision Date January 26, 1996
Days to Decision 169 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
40d slower than avg
Panel avg: 129d · This submission: 169d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FPA Device Classification - Class 2, Special Controls

Product Code FPA Set, Administration, Intravascular
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5440
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 - FPA Set, Administration, Intravascular

All 602
Devices cleared under the same product code (FPA) and FDA review panel - the closest regulatory comparables to K953746.
IVAC NEEDLE FREE VALVE ADMINISTRATION SETS
K960280 · Y · Apr 1996
ANGIOFLUSH II FLUID MANAGEMENT SYSTEM
K953825 · AngioDynamics, Inc. · Feb 1996
POLYFIN QR SUBCUTANEOUS INFUSION SET
K954969 · Medtronic Minimed · Feb 1996
SIMS DELTEC ANTI-SIPHON VALVE
K954870 · Sims Deltec, Inc. · Dec 1995
ICU EXTENSION KIT
K954813 · Icu Medical, Inc. · Nov 1995
LOW PROFILE SAFSITE Y-SITE
K954123 · B.Braun Medical, Inc. · Nov 1995