Cleared Traditional

AEROQUIP SAFESTART (TM) IV CATH (TM) SYSTEM (K970644) - FDA 510(k) Clearance

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

K970644 · Aeroquip Medical Products · General Hospital
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Jul 1997
Decision
161d
Days
Class 2
Risk

K970644 is an FDA 510(k) clearance for the AEROQUIP SAFESTART (TM) IV CATH (TM) SYSTEM. Classified as Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days (product code FOZ), Class II - Special Controls.

Submitted by Aeroquip Medical Products (Ann Arbor, US). The FDA issued a Cleared decision on July 31, 1997 after a review of 161 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 Aeroquip Medical Products devices

Submission Details

510(k) Number K970644 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 20, 1997
Decision Date July 31, 1997
Days to Decision 161 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
32d slower than avg
Panel avg: 129d · This submission: 161d
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 125
Devices cleared under the same product code (FOZ) and FDA review panel - the closest regulatory comparables to K970644.
INTROCAN SAFETY IV CATHETER
K982805 · B.Braun Medical, Inc. · Jan 1999
BRAUN PREFILLED SYRINGE
K970736 · B.Braun Medical, Inc. · Dec 1998
VAXESS PERIPHERALLY INSERTED CENTRAL CATHETER
K980566 · Boston Scientific Corp · Sep 1998
CVP POLYURETHANE CATHETER
K961552 · Abbott Laboratories · Feb 1997
0.9% SODIUM CHLORIDE DILUENT IN PLASTIC SYRINGE
K953805 · Abbott Laboratories · Jun 1996
ABRM CATHETER
K950118 · Cook, Inc. · Feb 1996