Cleared Traditional

K212258 - Medline Cardiovascular Procedure Kit (FDA 510(k) Clearance)

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

K212258 · Medline Industries, Inc. · General & Plastic Surgery device
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Dec 2021
Decision
136d
Days
Class 2
Risk

K212258 is an FDA 510(k) clearance for the Medline Cardiovascular Procedure Kit. Classified as General Surgery Tray (product code LRO), Class II - Special Controls.

Submitted by Medline Industries, Inc. (Northfiled, US). The FDA issued a Cleared decision on December 3, 2021 after a review of 136 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 Medline Industries, Inc. devices

Submission Details

510(k) Number K212258 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 20, 2021
Decision Date December 03, 2021
Days to Decision 136 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
PCCP Authorized No
Regulatory Context
Review time vs. panel average
22d slower than avg
Panel avg: 114d · This submission: 136d
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.