Cleared Traditional

K813345 - CRITIKON I.V. CATHETER PLACEMENT UNIT

K813345 is an FDA 510(k) clearance for CRITIKON I.V. CATHETER PLACEMENT UNIT, manufactured by Critikon Company, LLC. The device is a Class 2 General Hospital device with product code FOZ cleared through the Traditional 510(k) pathway after a 48-day FDA review.

K813345 · Critikon Company, LLC · General Hospital
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Jan 1982
Decision
48d
Days
Class 2
Risk

K813345 is an FDA 510(k) clearance for the CRITIKON I.V. CATHETER PLACEMENT UNIT. Classified as Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days (product code FOZ), Class II - Special Controls.

Submitted by Critikon Company, LLC (Mchenry, US). The FDA issued a Cleared decision on January 12, 1982 after a review of 48 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 Critikon Company, LLC devices

FDA 510(k) Submission Details - K813345

510(k) Number K813345 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 25, 1981
Decision Date January 12, 1982
Days to Decision 48 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
81d faster than avg
Panel avg: 129d · This submission: 48d
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 302
Devices cleared under the same product code (FOZ) and FDA review panel - the closest regulatory comparables to K813345.
DESERET ANGIO GUIDE
K821577 · Warner-Lambert Co. · Jun 1982
DESERET SUBCLAVIAN JUGULAR CATHETER SET
K821371 · Warner-Lambert Co. · Jun 1982
DESERET INTRACATH INTRAVENOUS CATHETER
K821372 · Warner-Lambert Co. · Jun 1982
VERSCHLUBSTOPFEN COMB-CLOSING STOPPER
K813396 · Burron Medical Products, Inc. · Jan 1982
B-D HEPARINIZED LONGDWEL I.V. CATHETER
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INTRAVASCULAR CATHETER
K803238 · G.D. Searle and Co. · Apr 1981