Cleared Traditional

K850398 - NU-CATH EMERGENCY KIT

K850398 is the FDA 510(k) clearance for NU-CATH EMERGENCY KIT by Intl. Medical Devices , Ltd.. It is a Class 2 General Hospital device (product code FOZ) cleared through the Traditional 510(k) pathway after a 54-day FDA review.

K850398 · Intl. Medical Devices , Ltd. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1985
Decision
54d
Days
Class 2
Risk

K850398 is an FDA 510(k) clearance for the NU-CATH EMERGENCY KIT. Classified as Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days (product code FOZ), Class II - Special Controls.

Submitted by Intl. Medical Devices , Ltd. (Los Angeles, US). The FDA issued a Cleared decision on March 27, 1985 after a review of 54 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 Intl. Medical Devices , Ltd. devices

Submission Details

510(k) Number K850398 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 01, 1985
Decision Date March 27, 1985
Days to Decision 54 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
75d faster than avg
Panel avg: 129d · This submission: 54d
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 142
Devices cleared under the same product code (FOZ) and FDA review panel - the closest regulatory comparables to K850398.
POLYCATH-H CATHETER
K854308 · Abbott Laboratories · Apr 1986
TERUMO SURFLO ETFE I.V. CATHETER
K854566 · Terumo Medical Corp. · Jan 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
INJECTION CAP
K834480 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Feb 1984