Cleared Traditional

K904122 - INSYTE-A ARTERIAL CATHETERIZATION UNIT

K904122 is an FDA 510(k) clearance for INSYTE-A ARTERIAL CATHETERIZATION UNIT, manufactured by Deseret Medical, Inc.. The device is a Class 2 General Hospital device with product code FOZ cleared through the Traditional 510(k) pathway after a 28-day FDA review.

K904122 · Deseret Medical, Inc. · General Hospital
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Oct 1990
Decision
28d
Days
Class 2
Risk

K904122 is an FDA 510(k) clearance for the INSYTE-A ARTERIAL CATHETERIZATION UNIT. Classified as Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days (product code FOZ), Class II - Special Controls.

Submitted by Deseret Medical, Inc. (Sandy, US). The FDA issued a Cleared decision on October 4, 1990 after a review of 28 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 Deseret Medical, Inc. devices

FDA 510(k) Submission Details - K904122

510(k) Number K904122 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 06, 1990
Decision Date October 04, 1990
Days to Decision 28 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
101d faster than avg
Panel avg: 129d · This submission: 28d
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 415
Devices cleared under the same product code (FOZ) and FDA review panel - the closest regulatory comparables to K904122.
SAFE SYTE I.V. CATHETER PLACEMENT UNIT
K904648 · Deseret Medical, Inc. · Dec 1990
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VIALON OBTURATOR
K904121 · Deseret Medical, Inc. · Nov 1990
KENDALL SAFETRAK(TM) HIGH FLOW CATHETER
K903732 · Kendall Healthcare Products Co. Div.Of Tyco Health · Oct 1990
VAS-CATH TRIFUSION TRIPLE LUMEN INFUSION CATHETER
K895597 · Vas-Cath, Inc. · Sep 1990
SPLIT-SECOND INTRODUCER
K902527 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Sep 1990