Cleared Traditional

K844193 - QUINTON INJECTION SEALING CAP

K844193 is an FDA 510(k) clearance for QUINTON INJECTION SEALING CAP, manufactured by Quinton, Inc.. The device is a Class 2 General Hospital device with product code FOZ cleared through the Traditional 510(k) pathway after a 199-day FDA review.

K844193 · Quinton, Inc. · General Hospital
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May 1985
Decision
199d
Days
Class 2
Risk

K844193 is an FDA 510(k) clearance for the QUINTON INJECTION SEALING CAP. 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 May 17, 1985 after a review of 199 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

FDA 510(k) Submission Details - K844193

510(k) Number K844193 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 30, 1984
Decision Date May 17, 1985
Days to Decision 199 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
70d slower than avg
Panel avg: 129d · This submission: 199d
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 415
Devices cleared under the same product code (FOZ) and FDA review panel - the closest regulatory comparables to K844193.
TELET-LEX MEDICAL IV CATHETER PLACEMENT
K851142 · Teleflexmedical, Inc. · Jul 1985
DESERET ARTERIAL CATHETER
K851327 · Parke-Davis Co. · Jun 1985
SPECTRUM(TENTATIVE)
K852078 · Parke-Davis Co. · Jun 1985
QUINTON WHITE SEALING CAP
K850369 · Quinton, Inc. · Feb 1985
DESERET INTRAVASCULAR CATHETER
K843033 · Parke-Davis Co. · Dec 1984
DESERET SUBCLAVIAN JUGULAR CATHETER SET
K844113 · Parke-Davis Co. · Nov 1984