Cleared Special

K022236 - RECOVERY FILTER SYSTEM

K022236 is the FDA 510(k) clearance for RECOVERY FILTER SYSTEM by C.R. Bard, Inc.. It is a Class 2 Cardiovascular device (product code DTK) cleared through the Special 510(k) pathway after a 139-day FDA review.

K022236 · C.R. Bard, Inc. · Cardiovascular device
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Nov 2002
Decision
139d
Days
Class 2
Risk

K022236 is an FDA 510(k) clearance for the RECOVERY FILTER SYSTEM, MODEL RF-048F. Classified as Filter, Intravascular, Cardiovascular (product code DTK), Class II - Special Controls.

Submitted by C.R. Bard, Inc. (Tempe, US). The FDA issued a Cleared decision on November 27, 2002 after a review of 139 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.3375 - the FDA cardiovascular device oversight framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all C.R. Bard, Inc. devices

Submission Details

510(k) Number K022236 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 11, 2002
Decision Date November 27, 2002
Days to Decision 139 days
Submission Type Special
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
14d slower than avg
Panel avg: 125d · This submission: 139d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code DTK Filter, Intravascular, Cardiovascular
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.3375
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 - DTK Filter, Intravascular, Cardiovascular

All 42
Devices cleared under the same product code (DTK) and FDA review panel - the closest regulatory comparables to K022236.
GUNTHER TULIP VENA CAVA FILTER SET
K043509 · Cook, Inc. · May 2005
GUNHTER TULIP VENA CAVA MREYE FILTER AND RETRIEVAL SET
K032426 · Cook, Inc. · Oct 2003
RECOVERY FILTER SYSTEM, MODEL RF-048F
K031328 · C.R. Bard, Inc. · Jul 2003
CORDIS OPTEASE PERMANENT VENA CAVA FILTER, MODELS 466-F200A, 466-F200B
K023116 · Cordis Corp. · Oct 2002
TRAPEASE PERMANENT VENA CAVA FILTER AND INTRODUCTION KIT, MODEL 466-P306A
K010083 · Cordis Corp. · Jun 2001
TRAPEASE PERMANENT VENA FILTER AND INTRODUCTION KIT, MODELS 466-P306A AND 466-P306B
K003964 · Cordis Corp. · Jan 2001