Cleared Traditional

K800525 - MEDICAL COMPONENTS IV CATHETER

K800525 is an FDA 510(k) clearance for MEDICAL COMPONENTS IV CATHETER, manufactured by Medical Components, Inc.. The device is a Class 2 General Hospital device with product code FOZ cleared through the Traditional 510(k) pathway after a 32-day FDA review.

K800525 · Medical Components, Inc. · General Hospital
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Apr 1980
Decision
32d
Days
Class 2
Risk

K800525 is an FDA 510(k) clearance for the MEDICAL COMPONENTS IV CATHETER. Classified as Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days (product code FOZ), Class II - Special Controls.

Submitted by Medical Components, Inc. (Mchenry, US). The FDA issued a Cleared decision on April 8, 1980 after a review of 32 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 Medical Components, Inc. devices

FDA 510(k) Submission Details - K800525

510(k) Number K800525 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 07, 1980
Decision Date April 08, 1980
Days to Decision 32 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
97d faster than avg
Panel avg: 129d · This submission: 32d
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 299
Devices cleared under the same product code (FOZ) and FDA review panel - the closest regulatory comparables to K800525.
BURRON MICROCATH INTRA. CATH. PLACEMENTT
K801941 · Burron Medical Products, Inc. · Aug 1980
ERYTHROCATH INTRAVENOUS CATHETER PLA. U.
K801414 · G.D. Searle and Co. · Aug 1980
INJECTION SITE, CODE NO. 3100
K800786 · Quest Medical, Inc. · May 1980
JELCO WINGED INTRAVASCULAR CATHETER
K791918 · Jelco Laboratories · Oct 1979
SILASTIC INTRAVENOUS CATHETER UNIT
K790914 · Dow Corning Corp. Healthcare Industries Materials · Jul 1979
CATHETER METAL HUB/RADIOPAQUE
K790967 · Jelco Laboratories · Jun 1979