Cleared Traditional

K790968 - CATHETER METAL HUB/NONRADIOPAQUE

K790968 is an FDA 510(k) clearance for CATHETER METAL HUB/NONRADIOPAQUE, manufactured by Jelco Laboratories. The device is a Class 2 General Hospital device with product code FOZ cleared through the Traditional 510(k) pathway after a 20-day FDA review.

K790968 · Jelco Laboratories · General Hospital
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Jun 1979
Decision
20d
Days
Class 2
Risk

K790968 is an FDA 510(k) clearance for the CATHETER METAL HUB/NONRADIOPAQUE. Classified as Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days (product code FOZ), Class II - Special Controls.

Submitted by Jelco Laboratories (Mchenry, US). The FDA issued a Cleared decision on June 11, 1979 after a review of 20 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 Jelco Laboratories devices

FDA 510(k) Submission Details - K790968

510(k) Number K790968 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 22, 1979
Decision Date June 11, 1979
Days to Decision 20 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
109d faster than avg
Panel avg: 129d · This submission: 20d
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 348
Devices cleared under the same product code (FOZ) and FDA review panel - the closest regulatory comparables to K790968.
SILASTIC INTRAVENOUS CATHETER UNIT
K790914 · Dow Corning Corp. Healthcare Industries Materials · Jul 1979
CATHETER METAL HUB/RADIOPAQUE
K790967 · Jelco Laboratories · Jun 1979
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
IV CATHETER HUB
K771381 · Jelco Laboratories · Oct 1977