510(k) Report

510(k) · Cleared

Recalled · 2008

Malleable Single Stage Venous Cannula with Carmeda Bioactive Surface, Model CB681XX Series

K033264510(k) SpecialCleared Oct 31, 200322-day reviewClass II21 CFR 870.4210Recalls 1

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

Medtronic Perfusion Systems · DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass

Cleared on Oct 31, 2003 as substantially equivalent to K022272 (Medtronic Cardiac Surgical Products, 2003) after a 22-day review. Its family tree reaches back 2 generations to 1985. 6 later devices descend from it. It has been recalled once.

Decided
Oct 31, 2003
Review
22 days
Class
Class II
Product code
DWF
Recalls
1
Predicates
2

Its longest line of descent runs back 2 generations to K845045 (1985). 6 later devices descend from it, 1 citing it directly.

Descendants, by year cleared 2011: 1 descendant cleared2012: 1 descendant cleared2014: 1 descendant cleared2026: 2 descendants cleared2025: 1 descendant clearedK845045 · Venous Return Catheter SS-1 · Dlp, Inc. · 1985 · recalledK022272 · Malleable Single Stage Venous Cannula, Models 68112-68140 (15 Total Codes) · Medtronic Cardiac Surgical Products · 2003 · recalled1990200020102020
Descendants, by generation 1 generation forward: 1 descendant2 generations forward: 1 descendant3 generations forward: 2 descendants4 generations forward: 1 descendant5 generations forward: 1 descendant K022272 · Malleable Single Stage Venous Cannula, Models 68112-68140 (15 Total Codes) · Medtronic Cardiac Surgical Products · 2003 · recalledK845045 · Venous Return Catheter SS-1 · Dlp, Inc. · 1985 · recalled0+5
  1. Root · 2 generations backK845045 Venous Return Catheter SS-1Dlp, Inc. · 1985 · Recalled
  2. 1 generation backK022272 Malleable Single Stage Venous Cannula, Models 68112-68140 (15 Total…Medtronic Cardiac Surgical Products · 2003 · Recalled
  3. This deviceK033264 Malleable Single Stage Venous Cannula with Carmeda Bioactive…Medtronic Perfusion Systems · 2003
  4. Descendant · cites it directly · 5 of its ownK111972 Affinity CP Centrifugal Pump, Resting Heart Sys.,Myotherm…Medtronic, Inc. · 2011
  5. Descendant · 2 generations on · 4 of its ownK120988 DLP Single Stage Venous Cannula, DLP Right Angle Single Stage Venous…Medtronic, Inc. · 2012 · Recalled
  6. Descendant · 3 generations on · 2 of its ownK140165 MC2 Two-Stage Venous Cannula, Oval MC2 Two-Stage Venous Cannula…Medtronic, Inc. · 2014
  7. Descendant · 4 generations on · 1 of its ownK251258 MC2™ Two-Stage Venous Cannula; MC2X™ Three-Stage Venous CannulaMedtronic, Inc. · 2025
  8. Descendant · 5 generations on · 0 of its ownK262052 Tri Stage Venous CannulaeSorin Group Italia S.R.L. · 2026

Showing 5 of 6 descendants. See all descendants

Descendants cleared per year

2011: 12012: 12014: 12025: 12026: 2
2011high 2 (2026) · low 0 (2013)2026

Most influential descendants

Showing 5 of 6 · See all
  • K111972Affinity CP Centrifugal Pump, Resting Heart Sys.,Myotherm Cardioplegia Deliv.,Affinity…Medtronic, Inc. · 2011 · cites it directly5descendants
  • K120988DLP Single Stage Venous Cannula, DLP Right Angle Single Stage Venous Cannula, DLP Single…Medtronic, Inc. · 2012 · 2 generations on4descendants
  • K140165MC2 Two-Stage Venous Cannula, Oval MC2 Two-Stage Venous Cannula, Thin Wall Two-Stage…Medtronic, Inc. · 2014 · 3 generations on2descendants
  • K251258MC2™ Two-Stage Venous Cannula; MC2X™ Three-Stage Venous CannulaMedtronic, Inc. · 2025 · 4 generations on1descendant
  • K262052Tri Stage Venous CannulaeSorin Group Italia S.R.L. · 2026 · 5 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−2K845045Venous Return Catheter SS-1Dlp, Inc.19853
−1K022272Malleable Single Stage Venous Cannula, Models 68112-68140 (15 Total Codes)Medtronic Cardiac Surgical Products20033
0 (this device)K033264Malleable Single Stage Venous Cannula with Carmeda Bioactive Surface, Model…Medtronic Perfusion Systems2003—
+1K111972Affinity CP Centrifugal Pump, Resting Heart Sys.,Myotherm Cardioplegia…Medtronic, Inc.2011—
+2K120988DLP Single Stage Venous Cannula, DLP Right Angle Single Stage Venous Cannula…Medtronic, Inc.20122
+3K140165MC2 Two-Stage Venous Cannula, Oval MC2 Two-Stage Venous Cannula, Thin Wall…Medtronic, Inc.2014—
+4K251258MC2™ Two-Stage Venous Cannula; MC2X™ Three-Stage Venous CannulaMedtronic, Inc.2025—
+5K262052Tri Stage Venous CannulaeSorin Group Italia S.R.L.2026—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201110
201210
201410
202510
202620
FIG. 1 — Lineage of K033264, 1985–2026Source: 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), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in DWF? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new DWF device

  1. #1 K251258 MC2™ Two-Stage Venous Cannula; MC2X™…score 14.6 · 8 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against? (2)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.

TypeNumberDeviceApplicantDecidedRecalls
*K022272Malleable Single Stage Venous Cannula, Models 68112-68140 (15 Total Codes)Medtronic Cardiac Surgical Products20033
Kept off the family treeK891868FDA’s K891868 is Patient Examination Glove (Latex)
Our reading of the summary gave K891868, FDA’s number for Patient Examination Glove (Latex) (Bber Sound Rubber Industrial Co., Ltd.). Its FDA name has none of the distinctive words the summary uses for the device it names, “Extracorporeal Circuit with Bio-Active Surface”. Kept off the family tree.
Summary page 1
…e Single Stage Venous Cannula KO22272 Extracorporeal Circuit with Bio-Active Surface K8918687 Device Description: The Malleable Single Stage Venous Cannula with CarmedaB BioActive Surface, is designed for u…
Bber Sound Rubber Industrial Co., Ltd.1989—

Also cleared against K022272: 1 other device →

What descends from it? (6)

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

NumberDeviceApplicantDecidedDescendants
K111972Affinity CP Centrifugal Pump, Resting Heart Sys.,Myotherm Cardioplegia Deliv.,Affinity…Medtronic, Inc.20115

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

Recalls of this device

DateClassRecallRoot causeReason
May 9, 2008Not classifiedZ-1924-2008Nonconforming Material/ComponentMedtronic is recalling selected Carmeda-coated cardiopulmonary bypass (CPB) products (e.g., oxygenators, reservoirs, pumps, cannulae and tubing packs) that were manufactured with contaminated heparin. Medtronic's heparin supplier recently…

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • The line of descent spans 18 years and passes through 3 companies; a new generation was cleared every 17.8 years on median.
  • 2 of the 2 ancestors have a recall of any class.
  • Of its descendants, K111972 (Medtronic, Inc., 2011) has gone furthest, with 5 descendants of its own.
  • 1 other device also cites its predicate K022272.

How does its category compare?

All DWF devices

DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · DWF

4in 2025

2007: 22008: 62009: 82010: 32011: 52012: 102013: 92014: 142015: 92016: 32017: 52018: 52019: 32020: 32021: 52022: 22023: 22024: 32025: 42026 (partial year): 8
2007high 14 (2014) · low 2 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · DWF

89in 2025

2008: 95 days median2009: 148 days median2010: 62 days median2011: 85 days median2012: 110 days median2013: 110 days median2014: 110 days median2015: 46 days median2016: 32 days median2017: 127 days median2018: 30 days median2019: 120 days median2020: 30 days median2021: 358 days median2024: 29 days median2025: 89 days median2026 (partial year): 81 days median
2007high 358 (2021) · low 29 (2024)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · DWF

4in 2024

2007: 252008: 252009: 212010: 262011: 132012: 372013: 14, 1 Class I2014: 62015: 3, 1 Class I2016: 32017: 2, 1 Class I2018: 102019: 22021: 32024: 42026 (partial year): 20
2007high 37 (2012) · low 0 (2020)2026

Class I (3 since 2007) Class II/III not classified

Adverse event reports per year · DWF

1,020in 2025

2007: 1212008: 1262009: 992010: 1972011: 2122012: 2332013: 2382014: 3252015: 2182016: 1442017: 1012018: 1182019: 1792020: 1422021: 1622022: 2762023: 4702024: 4012025: 1,020
2007high 1,020 (2025) · low 99 (2009)2025

MAUDE reports naming product code DWF, 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
20072—25121
200869525126
200981482199
201036226197
201158513212
20121011037233
2013911014 (1)238
2014141106325
20159463 (1)218
20163323144
201751272 (1)101
201853010118
201931202179
20203300142
202153583162
20222—0276
20232—0470
20243294401
202548901,020
202688120—

What is it indicated for?

These cannulae are intended for collection of venous blood from the right side of the heart via the superior and inferior vena cava during cardiopulmonary bypass surgery up to six hours or less.

Indications for use as stated in the FDA summary.

Also cleared against K022272

1 other device cites the same predicate.

  • K120988DLP Single Stage Venous Cannula, DLP Right Angle Single Stage Venous Cannula, DLP Single Stage Venous…Medtronic, Inc. · 20122 recalls

More from Medtronic Perfusion Systems

29 FDA decisions under this applicant name. See the company

  • K240666Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface (BB811); Affinity Fusion…Medtronic Perfusion Systems · 2024
  • K181954autoLog IQ Autotransfusion SystemMedtronic Perfusion Systems · 2018
  • K123351Affinity AF100 Arterial Filter with Carmeda Bioactive SurfaceMedtronic Perfusion Systems · 2013
  • K101186Affinity Vard Sub-Assembly for CPS (Carmeda Coated), Purgeline (Uncoated), Holding BagMedtronic Perfusion Systems · 2010
  • K090869Mircsp (Minimally Invasive Retrograde Coronary Sinus Perfusion) Manual Inflate Cannula, Model 94113TDMedtronic Perfusion Systems · 2009

Recent decisions in DWF

The DWF category page

  • K263092Dual Stage Venous CannulaeSorin Group Italia S.R.L. · 2026
  • K262052Tri Stage Venous CannulaeSorin Group Italia S.R.L. · 2026
  • K260195Elongated One-Piece Arterial (EOPA) 3D™ Arterial CannulaeMedtronic, Inc. · 20262 recalls
  • K250937Venous Return CannulaeLivaNova USA, Inc. · 2026
  • K260043Smart Reactors Camouflage Coated Extracorporeal Cardiopulmonary Tubing Set (SR180C)Smart Reactors · 2026

https://510kreport.com/device/K033264 · printed Nov 6, 2026

Cite this page

510(k) Report. “K033264: Malleable Single Stage Venous Cannula with Carmeda Bioactive Surface, Model CB681XX Series.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K033264

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Record history
  • FDA decision record loaded May 2, 2026
  • Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026