Cleared Traditional

K152136 - Recovery Cone Removal System

K152136 is an FDA 510(k) clearance for Recovery Cone Removal System, manufactured by C.R. Bard, Inc.. The device is a Class 2 Cardiovascular device with product code MMX cleared through the Traditional 510(k) pathway after a 202-day FDA review.

K152136 · C.R. Bard, Inc. · Cardiovascular device
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Feb 2016
Decision
202d
Days
Class 2
Risk

K152136 is an FDA 510(k) clearance for the Recovery Cone Removal System. Classified as Device, Percutaneous Retrieval (product code MMX), Class II - Special Controls.

Submitted by C.R. Bard, Inc. (Tempe, US). The FDA issued a Cleared decision on February 18, 2016 after a review of 202 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.5150 - the FDA cardiovascular device oversight 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 Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all C.R. Bard, Inc. devices

FDA 510(k) Submission Details - K152136

510(k) Number K152136 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 31, 2015
Decision Date February 18, 2016
Days to Decision 202 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
77d slower than avg
Panel avg: 125d · This submission: 202d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MMX Device Classification - Class 2, Special Controls

Product Code MMX Device, Percutaneous Retrieval
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.5150
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 Cardiovascular devices follow this clearance model.

Regulatory Peers - MMX Device, Percutaneous Retrieval

All 23
Devices cleared under the same product code (MMX) and FDA review panel - the closest regulatory comparables to K152136.
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EN Snare Endovascular Snare System
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