Cleared Traditional

K050654 - AMSINO I.V. START KIT

K050654 is an FDA 510(k) clearance for AMSINO I.V. START KIT, manufactured by Amsino International, Inc.. The device is a Class 2 General & Plastic Surgery device with product code LRS cleared through the Traditional 510(k) pathway after a 49-day FDA review.

K050654 · Amsino International, Inc. · General & Plastic Surgery device
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May 2005
Decision
49d
Days
Class 2
Risk

K050654 is an FDA 510(k) clearance for the AMSINO I.V. START KIT. Classified as I.v. Start Kit (product code LRS), Class II - Special Controls.

Submitted by Amsino International, Inc. (Pomona, US). The FDA issued a Cleared decision on May 2, 2005 after a review of 49 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 880.5200 - the FDA general and plastic surgery 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 Amsino International, Inc. devices

FDA 510(k) Submission Details - K050654

510(k) Number K050654 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 14, 2005
Decision Date May 02, 2005
Days to Decision 49 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
66d faster than avg
Panel avg: 115d · This submission: 49d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LRS Device Classification - Class 2, Special Controls

Product Code LRS I.v. Start Kit
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5200
Definition This Product Code Has Been Established In Accordance With The May 20, 1997, Guidance Entitled, Convenience Kits Interim Regulatory Guidance, Found At Http://www.fda.gov/downloads/medicaldevices/deviceregulationandguidance/guidancedocuments/ucm080217.pdf. This Type Of Convenience Kit, As Listed In The Guidance Above, Is Under Enforcement Discretion, And Does Not Require A Premarket Notification (510(k)) To Market If It Meets All Criteria In The Guidance.
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 & Plastic Surgery devices follow this clearance model.

Regulatory Peers - LRS I.v. Start Kit

All 16
Devices cleared under the same product code (LRS) and FDA review panel - the closest regulatory comparables to K050654.
IV START KIT
K963722 · Grand Medical Products · Nov 1996
B. BRAUN IV START KITS
K950184 · B. Braun of America, Inc. · Mar 1995
PERSONAL HEARING SYSTEM
K944041 · Resound Corp. · Dec 1994
SAFESTART VASCULAR ACCESS START KIT
K943941 · Becton Dickinson Vascular Access, Inc. · Oct 1994
IV START KIT
K935684 · Cush Medical Products · Jun 1994
I.V. STARTPAK VASCULAR ACCESS START KIT
K942238 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Jun 1994