Cleared Traditional

K940646 - ORTHOPEDIC TRAY PRODUCT LINE

K940646 is an FDA 510(k) clearance for ORTHOPEDIC TRAY PRODUCT LINE, manufactured by Cushindu. The device is a Class 1 General & Plastic Surgery device with product code LRP cleared through the Traditional 510(k) pathway after a 24-day FDA review.

K940646 · Cushindu · General & Plastic Surgery device
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Mar 1994
Decision
24d
Days
Class 1
Risk

K940646 is an FDA 510(k) clearance for the ORTHOPEDIC TRAY PRODUCT LINE. Classified as Tray, Surgical (product code LRP), Class I - General Controls.

Submitted by Cushindu (Piney Flats, US). The FDA issued a Cleared decision on March 11, 1994 after a review of 24 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4800 - 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 Cushindu devices

FDA 510(k) Submission Details - K940646

510(k) Number K940646 FDA.gov
FDA Decision Cleared Substantially Equivalent - De Novo Granted (SEKD)
Date Received February 15, 1994
Decision Date March 11, 1994
Days to Decision 24 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
91d faster than avg
Panel avg: 115d · This submission: 24d
Pathway characteristics
Predicate-based equivalence.

LRP Device Classification - Class 1, General Controls

Product Code LRP Tray, Surgical
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 878.4800
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - LRP Tray, Surgical

All 11
Devices cleared under the same product code (LRP) and FDA review panel - the closest regulatory comparables to K940646.
LACERATION TRAY
K963723 · Grand Medical Products · Nov 1996
OSTEOTECH MUSCULOSKELETAL TISSUE RECOVERY PACK
K951811 · Osteotech, Inc. · May 1995
EYE TRAY
K940239 · Cush Medical Products · Jun 1994
GENERAL SURGERY TRAY
K940444 · Cush Medical Products · Mar 1994
EYE TRAY
K912105 · Medical Device Inspection Co., Inc. · Aug 1991
SITE STERILIZATION TRAYS FOR OPHTHALMIC USE
K883098 · Site Microsurgical Systems, Inc. · Aug 1988