Cleared Special

K093773 - AMSINO I.V. ADMINISTRATION SET, AMSAFE3 I.V ADMINISTRATION SET, EXTENSION SETS

K093773 is an FDA 510(k) clearance for AMSINO I.V. ADMINISTRATION SET, manufactured by Amsino International, Inc.. The device is a Class 2 General Hospital device with product code FPA cleared through the Special 510(k) pathway after a 92-day FDA review.

K093773 · Amsino International, Inc. · General Hospital
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Optimized for regulatory review, auditing and printing
Mar 2010
Decision
92d
Days
Class 2
Risk

K093773 is an FDA 510(k) clearance for the AMSINO I.V. ADMINISTRATION SET, AMSAFE3 I.V ADMINISTRATION SET, EXTENSION SETS. Classified as Set, Administration, Intravascular (product code FPA), Class II - Special Controls.

Submitted by Amsino International, Inc. (Pomona, US). The FDA issued a Cleared decision on March 10, 2010 after a review of 92 days - within the typical 510(k) review window.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5440 - the FDA general hospital device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Amsino International, Inc. devices

FDA 510(k) Submission Details - K093773

510(k) Number K093773 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 08, 2009
Decision Date March 10, 2010
Days to Decision 92 days
Submission Type Special
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
37d faster than avg
Panel avg: 129d · This submission: 92d
Pathway characteristics
Modification to existing cleared device.

FPA Device Classification - Class 2, Special Controls

Product Code FPA Set, Administration, Intravascular
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5440
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 - FPA Set, Administration, Intravascular

All 772
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