Cleared Traditional

K023276 - AMSINO TRACHEOSTOMY CARE TRAY

K023276 is an FDA 510(k) clearance for AMSINO TRACHEOSTOMY CARE TRAY, manufactured by Amsino International, Inc.. The device is a Class 2 General & Plastic Surgery device with product code LRO cleared through the Traditional 510(k) pathway after a 69-day FDA review.

K023276 · Amsino International, Inc. · General & Plastic Surgery device
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Dec 2002
Decision
69d
Days
Class 2
Risk

K023276 is an FDA 510(k) clearance for the AMSINO TRACHEOSTOMY CARE TRAY. Classified as General Surgery Tray (product code LRO), Class II - Special Controls.

Submitted by Amsino International, Inc. (Ontario, US). The FDA issued a Cleared decision on December 9, 2002 after a review of 69 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4370 - 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 - K023276

510(k) Number K023276 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 01, 2002
Decision Date December 09, 2002
Days to Decision 69 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
46d faster than avg
Panel avg: 115d · This submission: 69d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LRO Device Classification - Class 2, Special Controls

Product Code LRO General Surgery Tray
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4370
Definition This Product Code Has Been Established In Accordance With The May 20, 1997, Guidance Entitled, Convenience Kits Interim Regulatory Guidance, Found At Www.fda.gov/cdrh/ode/convkit.html. 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 - LRO General Surgery Tray

All 66
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