Cleared Traditional

K853348 - L-CATH EXPANDO CATH

K853348 is an FDA 510(k) clearance for L-CATH EXPANDO CATH, manufactured by Luther Medical Products, Inc.. The device is a Class 2 General Hospital device with product code FOZ cleared through the Traditional 510(k) pathway after a 150-day FDA review.

K853348 · Luther Medical Products, Inc. · General Hospital
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Jan 1986
Decision
150d
Days
Class 2
Risk

K853348 is an FDA 510(k) clearance for the L-CATH EXPANDO CATH. Classified as Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days (product code FOZ), Class II - Special Controls.

Submitted by Luther Medical Products, Inc. (Santa Ana, US). The FDA issued a Cleared decision on January 9, 1986 after a review of 150 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 Luther Medical Products, Inc. devices

FDA 510(k) Submission Details - K853348

510(k) Number K853348 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 12, 1985
Decision Date January 09, 1986
Days to Decision 150 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
21d slower than avg
Panel avg: 129d · This submission: 150d
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 K853348.
POLYCATH-H CATHETER
K854308 · Abbott Laboratories · Apr 1986
VIAPIC CENTRAL LINE CATHETER
K860290 · Parke-Davis Co. · Mar 1986
TERUMO SURFLO ETFE I.V. CATHETER
K854566 · Terumo Medical Corp. · Jan 1986
JELCO & CATHLON IV STRIPED IV CATHETERS-RADIOPAGUL
K853701 · Critikon Company, LLC · Oct 1985
TELET-LEX MEDICAL IV CATHETER PLACEMENT
K851142 · Teleflexmedical, Inc. · Jul 1985
DESERET ARTERIAL CATHETER
K851327 · Parke-Davis Co. · Jun 1985