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
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
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.

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 1174
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K093773 · AMSINO I.V. ADMINISTRATION SET, AMSAFE3 I.V ADMINISTRATION SET, EXTENSION SETS
Download PDF FDA Summary Amsino International,…