Cleared Traditional

K802918 - ANTHRON CATHETER SET

K802918 is an FDA 510(k) clearance for ANTHRON CATHETER SET, manufactured by National Catheter Co. Div. Mallinckrodt. The device is a Class 2 General Hospital device with product code FOZ cleared through the Traditional 510(k) pathway after a 153-day FDA review.

K802918 · National Catheter Co. Div. Mallinckrodt · General Hospital
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Apr 1981
Decision
153d
Days
Class 2
Risk

K802918 is an FDA 510(k) clearance for the ANTHRON CATHETER SET. Classified as Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days (product code FOZ), Class II - Special Controls.

Submitted by National Catheter Co. Div. Mallinckrodt (Mchenry, US). The FDA issued a Cleared decision on April 21, 1981 after a review of 153 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 National Catheter Co. Div. Mallinckrodt devices

FDA 510(k) Submission Details - K802918

510(k) Number K802918 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 19, 1980
Decision Date April 21, 1981
Days to Decision 153 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
24d slower than avg
Panel avg: 129d · This submission: 153d
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 416
Devices cleared under the same product code (FOZ) and FDA review panel - the closest regulatory comparables to K802918.
VERSCHLUBSTOPFEN COMB-CLOSING STOPPER
K813396 · Burron Medical Products, Inc. · Jan 1982
B-D HEPARINIZED LONGDWEL I.V. CATHETER
K812137 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Nov 1981
INTRAVASCULAR CATHETER
K803238 · G.D. Searle and Co. · Apr 1981
BURRON MICROCATH INTRA. CATH. PLACEMENTT
K801941 · Burron Medical Products, Inc. · Aug 1980
L-CATH INTRAVENOUS PLACEMENT UNIT
K801575 · Luther Medical Products, Inc. · Aug 1980
ERYTHROCATH INTRAVENOUS CATHETER PLA. U.
K801414 · G.D. Searle and Co. · Aug 1980