Cleared Traditional

K951149 - SINGLE USE INSTRUMENT TRAY

K951149 is an FDA 510(k) clearance for SINGLE USE INSTRUMENT TRAY, manufactured by Medcare Custom Packaging, Inc.. The device is a Class 2 General & Plastic Surgery device with product code LRO cleared through the Traditional 510(k) pathway after a 24-day FDA review.

K951149 · Medcare Custom Packaging, Inc. · General & Plastic Surgery device
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Apr 1995
Decision
24d
Days
Class 2
Risk

K951149 is an FDA 510(k) clearance for the SINGLE USE INSTRUMENT TRAY. Classified as General Surgery Tray (product code LRO), Class II - Special Controls.

Submitted by Medcare Custom Packaging, Inc. (East Swanzey, US). The FDA issued a Cleared decision on April 6, 1995 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 878.4370 - 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 Medcare Custom Packaging, Inc. devices

FDA 510(k) Submission Details - K951149

510(k) Number K951149 FDA.gov
FDA Decision Cleared Substantially Equivalent - Special 510(k) (SESK)
Date Received March 13, 1995
Decision Date April 06, 1995
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. 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 35
Devices cleared under the same product code (LRO) and FDA review panel - the closest regulatory comparables to K951149.
MEDLINE RADIOLOGY-DIAGNOSTIC KITS
K962826 · Medline Industries, Inc. · Sep 1996
PARACENTESIS TRAYS
K961863 · Tri-Med, Inc. · May 1996
WOUND CLOSURE/LACERATION TRAY
K950295 · Customed, Inc. · Apr 1995
MILL-ROSE PERCUTANEOUS PROCEDURAL KIT
K935858 · Mill-Rose Laboratory · Feb 1994
E-Z PREP(R) TRAY WITH HIBICLENS(R)
K935483 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Feb 1994
ARGYLE TURKEL SAFETY PNEUMOTHORAX PROCEDURE TRAY
K934428 · Sherwood Medical Co. · Dec 1993