Cleared Traditional

K790914 - SILASTIC INTRAVENOUS CATHETER UNIT

K790914 is an FDA 510(k) clearance for SILASTIC INTRAVENOUS CATHETER UNIT, manufactured by Dow Corning Corp. Healthcare Industries Materials. The device is a Class 2 General Hospital device with product code FOZ cleared through the Traditional 510(k) pathway after a 50-day FDA review.

K790914 · Dow Corning Corp. Healthcare Industries Materials · General Hospital
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Jul 1979
Decision
50d
Days
Class 2
Risk

K790914 is an FDA 510(k) clearance for the SILASTIC INTRAVENOUS CATHETER UNIT. Classified as Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days (product code FOZ), Class II - Special Controls.

Submitted by Dow Corning Corp. Healthcare Industries Materials (Walker, US). The FDA issued a Cleared decision on July 3, 1979 after a review of 50 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 Dow Corning Corp. Healthcare Industries Materials devices

FDA 510(k) Submission Details - K790914

510(k) Number K790914 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 14, 1979
Decision Date July 03, 1979
Days to Decision 50 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
79d faster than avg
Panel avg: 129d · This submission: 50d
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 277
Devices cleared under the same product code (FOZ) and FDA review panel - the closest regulatory comparables to K790914.
ERYTHROCATH INTRAVENOUS CATHETER PLA. U.
K801414 · G.D. Searle and Co. · Aug 1980
INJECTION SITE, CODE NO. 3100
K800786 · Quest Medical, Inc. · May 1980
MEDICAL COMPONENTS IV CATHETER
K800525 · Medical Components, Inc. · Apr 1980
WHOLEY OCCLUSION BALLOON CATHETER
K772011 · Cook, Inc. · Jun 1979
I.V. START KIT
K780350 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Mar 1978
NEEDLE CONNECTING SET, BLUNT
K780105 · Abbott Laboratories · Feb 1978