Cleared Traditional

K212882 - SCOUT BX Delivery System

K212882 is an FDA 510(k) clearance for SCOUT BX Delivery System, manufactured by Merit Medical Systems, Inc.. The device is a Class 2 General & Plastic Surgery device with product code NEU cleared through the Traditional 510(k) pathway after a 210-day FDA review.

K212882 · Merit Medical Systems, Inc. · General & Plastic Surgery device
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Apr 2022
Decision
210d
Days
Class 2
Risk

K212882 is an FDA 510(k) clearance for the SCOUT BX Delivery System. Classified as Marker, Radiographic, Implantable (product code NEU), Class II - Special Controls.

Submitted by Merit Medical Systems, Inc. (South Jordan, US). The FDA issued a Cleared decision on April 8, 2022 after a review of 210 days - an extended review cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4300 - 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 Merit Medical Systems, Inc. devices

FDA 510(k) Submission Details - K212882

510(k) Number K212882 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 10, 2021
Decision Date April 08, 2022
Days to Decision 210 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
95d slower than avg
Panel avg: 115d · This submission: 210d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

NEU Device Classification - Class 2, Special Controls

Product Code NEU Marker, Radiographic, Implantable
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4300
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 - NEU Marker, Radiographic, Implantable

All 92
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