Cleared Traditional

CUSTOM WOUND MANAGEMENT KITS AND TRAYS (K901856) - FDA 510(k) Clearance

Class II General & Plastic Surgery device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K901856 · Medcare Custom Packaging, Inc. · General & Plastic Surgery device
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Aug 1990
Decision
99d
Days
Class 2
Risk

K901856 is an FDA 510(k) clearance for the CUSTOM WOUND MANAGEMENT KITS AND TRAYS. Classified as General Surgery Tray (product code LRO), Class II - Special Controls.

Submitted by Medcare Custom Packaging, Inc. (E Swanzey, US). The FDA issued a Cleared decision on August 1, 1990 after a review of 99 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

View all Medcare Custom Packaging, Inc. devices

Submission Details

510(k) Number K901856 FDA.gov
FDA Decision Cleared Substantially Equivalent - Direct De Novo (SESD)
Date Received April 24, 1990
Decision Date August 01, 1990
Days to Decision 99 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
16d faster than avg
Panel avg: 115d · This submission: 99d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 109
Devices cleared under the same product code (LRO) and FDA review panel - the closest regulatory comparables to K901856.
Medline General Surgery Tray
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E-Z PREP(R) TRAY WITH HIBICLENS(R)
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ARGYLE TURKEL SAFETY PNEUMOTHORAX PROCEDURE TRAY
K934428 · Sherwood Medical Co. · Dec 1993