Cleared Traditional

K803238 - INTRAVASCULAR CATHETER

K803238 is an FDA 510(k) clearance for INTRAVASCULAR CATHETER, manufactured by G.D. Searle and Co.. The device is a Class 2 General Hospital device with product code FOZ cleared through the Traditional 510(k) pathway after a 121-day FDA review.

K803238 · G.D. Searle and Co. · General Hospital
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Apr 1981
Decision
121d
Days
Class 2
Risk

K803238 is an FDA 510(k) clearance for the INTRAVASCULAR CATHETER. Classified as Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days (product code FOZ), Class II - Special Controls.

Submitted by G.D. Searle and Co. (Mchenry, US). The FDA issued a Cleared decision on April 23, 1981 after a review of 121 days - within the typical 510(k) review window.

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 G.D. Searle and Co. devices

FDA 510(k) Submission Details - K803238

510(k) Number K803238 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 23, 1980
Decision Date April 23, 1981
Days to Decision 121 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
8d faster than avg
Panel avg: 129d · This submission: 121d
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 278
Devices cleared under the same product code (FOZ) and FDA review panel - the closest regulatory comparables to K803238.
CRITIKON I.V. CATHETER PLACEMENT UNIT
K813345 · Critikon Company, LLC · Jan 1982
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
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