Cleared Traditional

K050558 - MODIFICATION TO: RECOVERY FILTER SYSTEM, MODEL RF-210F

K050558 is an FDA 510(k) clearance for MODIFICATION TO: RECOVERY FILTER SYSTEM, manufactured by C.R. Bard, Inc.. The device is a Class 2 Cardiovascular device with 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

FDA 510(k) Submission Details - K050558

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.

DTK Device Classification - Class 2, Special Controls

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 64
Devices cleared under the same product code (DTK) and FDA review panel - the closest regulatory comparables to K050558.
COOK CELECT VENA CAVA FILTER
K061815 · William Cook Europe Aps · Apr 2007
VENATECH LP BRACHIAL INTRODUCER SYSTEM (ANTECUBITAL)
K063217 · B.Braun Medical, Inc. · Jan 2007
BARD G2 FILTER SYSTEM - JUGULAR/SUBCLAVIAN DELIVERY KIT, MODEL RF-320J
K052578 · Bard Peripheral Vascular, Inc. · Nov 2005
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