Cleared Traditional

K905463 - GENERAL MEDICAL PROCEDURE KIT/SKIN PREP...

K905463 is the FDA 510(k) clearance for GENERAL MEDICAL PROCEDURE KIT/SKIN PREP... by Angiosystems, Inc.. It is a Class 2 General Hospital device (product code FOZ) cleared through the Traditional 510(k) pathway after a 48-day FDA review.

K905463 · Angiosystems, Inc. · General Hospital
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Jan 1991
Decision
48d
Days
Class 2
Risk

K905463 is an FDA 510(k) clearance for the GENERAL MEDICAL PROCEDURE KIT/SKIN PREPARATION. Classified as Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days (product code FOZ), Class II - Special Controls.

Submitted by Angiosystems, Inc. (Great Neck, US). The FDA issued a Cleared decision on January 22, 1991 after a review of 48 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 Angiosystems, Inc. devices

Submission Details

510(k) Number K905463 FDA.gov
FDA Decision Cleared Substantially Equivalent - De Novo Granted (SEKD)
Date Received December 05, 1990
Decision Date January 22, 1991
Days to Decision 48 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
81d faster than avg
Panel avg: 129d · This submission: 48d
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
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