Cleared Traditional

K940775 - INJECTION CAP

K940775 is an FDA 510(k) clearance for INJECTION CAP, manufactured by Medron, Inc.. The device is a Class 2 General Hospital device with product code FOZ cleared through the Traditional 510(k) pathway after a 113-day FDA review.

K940775 · Medron, Inc. · General Hospital
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Jun 1994
Decision
113d
Days
Class 2
Risk

K940775 is an FDA 510(k) clearance for the INJECTION CAP. Classified as Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days (product code FOZ), Class II - Special Controls.

Submitted by Medron, Inc. (Salt Lake City, US). The FDA issued a Cleared decision on June 15, 1994 after a review of 113 days - within the typical 510(k) review window.

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 Medron, Inc. devices

FDA 510(k) Submission Details - K940775

510(k) Number K940775 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 22, 1994
Decision Date June 15, 1994
Days to Decision 113 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
16d faster than avg
Panel avg: 129d · This submission: 113d
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

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