Cleared Traditional

K050558 - MODIFICATION TO: RECOVERY FILTER SYSTEM

K050558 is the FDA 510(k) clearance for MODIFICATION TO: RECOVERY FILTER SYSTEM by C.R. Bard, Inc.. It is a Class 2 Cardiovascular device (product code DTK) cleared through the Traditional 510(k) pathway after a 179-day FDA review.

K050558 · C.R. Bard, Inc. · Cardiovascular device
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Aug 2005
Decision
179d
Days
Class 2
Risk

K050558 is an FDA 510(k) clearance for the MODIFICATION TO: RECOVERY FILTER SYSTEM, MODEL RF-210F. 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 August 29, 2005 after a review of 179 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.3375 - 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

Submission Details

510(k) Number K050558 FDA.gov
FDA Decision Cleared Substantially Equivalent - Abbreviated 510(k) (SESU)
Date Received March 03, 2005
Decision Date August 29, 2005
Days to Decision 179 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
54d slower than avg
Panel avg: 125d · This submission: 179d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 K050558.
RECOVERY G2 FILTER SYSTEM - FEMORAL DELIVERY KIT, MODEL RF-310F
K073090 · C.R. Bard, Inc. · Jan 2008
GUNTHER TULIP VENA CAVA FILTER
K072240 · Cook, Inc. · Nov 2007
VENATECH LP BRACHIAL INTRODUCER SYSTEM (ANTECUBITAL)
K063217 · B.Braun Medical, Inc. · Jan 2007
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