Cleared Traditional

K840815 - LUER LOCKING ADAPTER(MATERIAL CHANGE)

K840815 is the FDA 510(k) clearance for LUER LOCKING ADAPTER(MATERIAL CHANGE) by Quinton, Inc.. It is a Class 2 General Hospital device (product code FOZ) cleared through the Traditional 510(k) pathway after a 255-day FDA review.

K840815 · Quinton, Inc. · General Hospital
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Nov 1984
Decision
255d
Days
Class 2
Risk

K840815 is an FDA 510(k) clearance for the LUER LOCKING ADAPTER(MATERIAL CHANGE). Classified as Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days (product code FOZ), Class II - Special Controls.

Submitted by Quinton, Inc. (Seattle, US). The FDA issued a Cleared decision on November 8, 1984 after a review of 255 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 Quinton, Inc. devices

Submission Details

510(k) Number K840815 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 27, 1984
Decision Date November 08, 1984
Days to Decision 255 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
126d slower than avg
Panel avg: 129d · This submission: 255d
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 271
Devices cleared under the same product code (FOZ) and FDA review panel - the closest regulatory comparables to K840815.
DESERET INTRAVASCULAR CATHETER
K843033 · Parke-Davis Co. · Dec 1984
DESERET SUBCLAVIAN JUGULAR CATHETER SET
K844113 · Parke-Davis Co. · Nov 1984
DESERET DENTRAL LINE CATHETER
K844219 · Parke-Davis Co. · Nov 1984
DESERET INFANT CENTRAL VENOUS CATHE-
K840116 · Parke-Davis Co. · Mar 1984
DESERET SUBCLAVIAN JUGULAR CATH. SET
K834227 · Parke-Davis Co. · Mar 1984
DESERET MULTILUMEN SUBCLAVIAN JUGULAR
K840183 · Parke-Davis Co. · Mar 1984