510(k) Report

510(k) · Cleared

Cleared

Cobe VVR 4000 Filtered Hardshell Venous Reservoir, Cobe Smarxt VVR 4000 Filtered Hardshell Venous Reservoir

K004046510(k) TraditionalCleared Apr 26, 2001118-day reviewClass II21 CFR 870.4230

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Cobe Cardiovascular, Inc. · DTP Defoamer, Cardiopulmonary Bypass

Cleared on Apr 26, 2001 after a 118-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 1 later device descends from it.

Decided
Apr 26, 2001
Review
118 days
Class
Class II
Product code
DTP
Recalls
None
Predicates
0

1 later device descends from it, 1 citing it directly.

Descendants, by year cleared 2009: 1 descendant cleared200020052010201520202025
  1. This deviceK004046 Cobe VVR 4000 Filtered Hardshell Venous Reservoir, Cobe Smarxt VVR…Cobe Cardiovascular, Inc. · 2001
  2. Descendant · cites it directly · 0 of its ownK092315 Sorin VVR 4000I and 4000I Smarxt Filtered Hardshell Venous ReservoirSorin Group Italia S.R.L. · 2009

Most influential descendants

Showing 1 of 1 · See all
  • K092315Sorin VVR 4000I and 4000I Smarxt Filtered Hardshell Venous ReservoirSorin Group Italia S.R.L. · 2009 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K004046Cobe VVR 4000 Filtered Hardshell Venous Reservoir, Cobe Smarxt VVR 4000…Cobe Cardiovascular, Inc.2001—
+1K092315Sorin VVR 4000I and 4000I Smarxt Filtered Hardshell Venous ReservoirSorin Group Italia S.R.L.2009—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200910
FIG. 1 — Lineage of K004046, 2001–2009Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

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  • Candidate predicates for a device like this, rankedin the report
  • Recall history across each candidate’s familyin the report
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What was it cleared against?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K092315Sorin VVR 4000I and 4000I Smarxt Filtered Hardshell Venous ReservoirSorin Group Italia S.R.L.20090

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Of its descendants, K092315 (Sorin Group Italia S.R.L., 2009) has gone furthest, with 0 descendants of its own.

How does its category compare?

All DTP devices

DTP Defoamer, Cardiopulmonary Bypass: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · DTP

1in 2010

2008: 12010: 1
2007high 1 (2008) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · DTP

Too few DTP 510(k)s in any year since 2007 to give a median.

Recalls per year · DTP

No recall names DTP since 2007.

Adverse event reports per year · DTP

1in 2016

2014: 32016: 1
2007high 3 (2014) · low 0 (2007)2025

MAUDE reports naming product code DTP, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—00
20081—00
20090—00
20101—00
20110—00
20120—00
20130—00
20140—03
20150—00
20160—01
20170—00
20180—00
20190—00
20200—00
20210—00
20220—00
20230—00
20240—00
20250—00
20260—0—

More from Cobe Cardiovascular, Inc.

43 FDA decisions under this applicant name. See the company

  • K050111Smarxt BMR 1900 Closed Venous Reservoir BagCobe Cardiovascular, Inc. · 2005
  • K042473Cobe Angel Whole Blood Separation SystemCobe Cardiovascular, Inc. · 2004
  • K040184Dideco Micro 40 PH.I.S.I.O. Adult Arterial FilterCobe Cardiovascular, Inc. · 2004
  • K033641Smarxt VVR4000I Plus Filtered Hardshell Venous Reservoir, Model 439914800Cobe Cardiovascular, Inc. · 2003
  • K030462Cobe Revolution Centrifugal Blood Pump with PC, Model 050300700Cobe Cardiovascular, Inc. · 20031 recall

Recent decisions in DTP

The DTP category page

  • K101186Affinity Vard Sub-Assembly for CPS (Carmeda Coated), Purgeline (Uncoated), Holding BagMedtronic Perfusion Systems · 2010
  • K082412Venous Bubble Trap, Model VBT 160; Venous Bubble Trap with Bioline Coating, Model BE-VBT 160, Beq-VBT 160Mapquet Cardiopulmonary AG · 2008
  • K002591Cobe Smarxt VVR 4000 Filtered Hardshell Venous ReservoirCobe Cardiovascular, Inc. · 2000
  • K990514Modification of Bard Quantum CVR, Model H-6770VRC.R. Bard, Inc. · 1999
  • K984322Dideco D920, Lilliput 1 Twin ReservoirDideco S.P.A. · 1999

https://510kreport.com/device/K004046 · printed Nov 5, 2026

Cite this page

510(k) Report. “K004046: Cobe VVR 4000 Filtered Hardshell Venous Reservoir, Cobe Smarxt VVR 4000 Filtered Hardshell Venous Reservoir.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K004046

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Record history
  • FDA decision record loaded May 2, 2026
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026