Cleared Traditional

L-CATH EXPANDO CATH (K853348) - FDA 510(k) Clearance

Class II General Hospital device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

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

Submission Details

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
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.

Device Classification

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 116
Devices cleared under the same product code (FOZ) and FDA review panel - the closest regulatory comparables to K853348.
VASCULAR ACCESS CATHETER W/ANTIMICROBIAL CUFF
K873050 · C.R. Bard, Inc. · Oct 1987
INSTRUCTION CHANGE FOR RIGHT ATRIAL/RAAF CATHETER
K864949 · Quinton, Inc. · Feb 1987
POLYCATH-H CATHETER
K854308 · Abbott Laboratories · Apr 1986
QUINTON INJECTION SEALING CAP
K844193 · Quinton, Inc. · May 1985
QUINTON WHITE SEALING CAP
K850369 · Quinton, Inc. · Feb 1985
LUER LOCKING ADAPTER(MATERIAL CHANGE)
K840815 · Quinton, Inc. · Nov 1984