510(k) Report

510(k) · Cleared

Recalled · Class II · 2024

Malleable Single Stage Venous Cannula, Models 68112-68140 (15 Total Codes)

K022272510(k) TraditionalCleared Jan 8, 2003177-day reviewClass II21 CFR 870.4210Recalls 3

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

Medtronic Cardiac Surgical Products · DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass

Cleared on Jan 8, 2003 as substantially equivalent to K845045 (Dlp, Inc., 1985) after a 177-day review. Its family tree reaches back 1 generation to 1985. 7 later devices descend from it. It has been recalled 3 times.

Decided
Jan 8, 2003
Review
177 days
Class
Class II
Product code
DWF
Recalls
3
Predicates
1

Its longest line of descent runs back 1 generation to K845045 (1985). 7 later devices descend from it, 2 citing it directly.

Descendants, by year cleared 2003: 1 descendant cleared2012: 1 descendant cleared2011: 1 descendant cleared2014: 1 descendant cleared2026: 2 descendants cleared2025: 1 descendant clearedK845045 · Venous Return Catheter SS-1 · Dlp, Inc. · 1985 · recalled1990200020102020
Descendants, by generation 1 generation forward: 2 descendants2 generations forward: 3 descendants3 generations forward: 1 descendant4 generations forward: 1 descendant K845045 · Venous Return Catheter SS-1 · Dlp, Inc. · 1985 · recalled0
  1. Root · 1 generation backK845045 Venous Return Catheter SS-1Dlp, Inc. · 1985 · Recalled
  2. This deviceK022272 Malleable Single Stage Venous Cannula, Models 68112-68140 (15 Total…Medtronic Cardiac Surgical Products · 2003
  3. Descendant · cites it directly · 6 of its ownK033264 Malleable Single Stage Venous Cannula with Carmeda Bioactive…Medtronic Perfusion Systems · 2003 · Recalled
  4. Descendant · 2 generations on · 5 of its ownK111972 Affinity CP Centrifugal Pump, Resting Heart Sys.,Myotherm…Medtronic, Inc. · 2011
  5. Descendant · cites it directly · 4 of its ownK120988 DLP Single Stage Venous Cannula, DLP Right Angle Single Stage Venous…Medtronic, Inc. · 2012 · Recalled
  6. Descendant · 2 generations on · 2 of its ownK140165 MC2 Two-Stage Venous Cannula, Oval MC2 Two-Stage Venous Cannula…Medtronic, Inc. · 2014
  7. Descendant · 3 generations on · 1 of its ownK251258 MC2™ Two-Stage Venous Cannula; MC2X™ Three-Stage Venous CannulaMedtronic, Inc. · 2025

Showing 5 of 7 descendants. See all descendants

Descendants cleared per year

2003: 12011: 12012: 12014: 12025: 12026: 2
2003high 2 (2026) · low 0 (2004)2026

Most influential descendants

Showing 5 of 7 · See all
  • K033264Malleable Single Stage Venous Cannula with Carmeda Bioactive Surface, Model CB681XX SeriesMedtronic Perfusion Systems · 2003 · cites it directly6descendants
  • K111972Affinity CP Centrifugal Pump, Resting Heart Sys.,Myotherm Cardioplegia Deliv.,Affinity…Medtronic, Inc. · 2011 · 2 generations on5descendants
  • K120988DLP Single Stage Venous Cannula, DLP Right Angle Single Stage Venous Cannula, DLP Single…Medtronic, Inc. · 2012 · cites it directly4descendants
  • K140165MC2 Two-Stage Venous Cannula, Oval MC2 Two-Stage Venous Cannula, Thin Wall Two-Stage…Medtronic, Inc. · 2014 · 2 generations on2descendants
  • K251258MC2™ Two-Stage Venous Cannula; MC2X™ Three-Stage Venous CannulaMedtronic, Inc. · 2025 · 3 generations on1descendant
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K845045Venous Return Catheter SS-1Dlp, Inc.19853
0 (this device)K022272Malleable Single Stage Venous Cannula, Models 68112-68140 (15 Total Codes)Medtronic Cardiac Surgical Products2003—
+1K033264Malleable Single Stage Venous Cannula with Carmeda Bioactive Surface, Model…Medtronic Perfusion Systems20031
+2K111972Affinity CP Centrifugal Pump, Resting Heart Sys.,Myotherm Cardioplegia…Medtronic, Inc.2011—
+1K120988DLP Single Stage Venous Cannula, DLP Right Angle Single Stage Venous Cannula…Medtronic, Inc.20122
+2K140165MC2 Two-Stage Venous Cannula, Oval MC2 Two-Stage Venous Cannula, Thin Wall…Medtronic, Inc.2014—
+3K251258MC2™ Two-Stage Venous Cannula; MC2X™ Three-Stage Venous CannulaMedtronic, Inc.2025—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200310
201110
201210
201410
202510
202620
FIG. 1 — Lineage of K022272, 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? (1)

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.

TypeNumberDeviceApplicantDecidedRecalls
*K845045Venous Return Catheter SS-1
Summary page 1
…Stage Venous Cannulae, Class II at 27 C f R 870.4210, cleared under tilO(k) Number K845045 c- /- Descrip…
Dlp, Inc.19853

Also cleared against K845045: 3 other devices →

What descends from it? (7)

2 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K033264Malleable Single Stage Venous Cannula with Carmeda Bioactive Surface, Model CB681XX SeriesMedtronic Perfusion Systems20036
K120988DLP Single Stage Venous Cannula, DLP Right Angle Single Stage Venous Cannula, DLP Single…Medtronic, Inc.20124

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

Recalls of this device

DateClassRecallRoot causeReason
Mar 19, 2024Class IIZ-1805-2024Process controlPotential for unsealed sterile packing.
Dec 14, 2011Not classifiedZ-0812-2012Labeling designInstructions for Use for the DLP Single Stage Venous Cannulae are in the process of being updated. The current precaution statement referencing ventricular assist procedures will be identified as a contraindication in the updated…
Dec 14, 2011Not classifiedZ-0810-2012Labeling designInstructions for Use for the DLP Single Stage Venous Cannulae are in the process of being updated. The current precaution statement referencing ventricular assist procedures will be identified as a contraindication in the updated…

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Its one ancestor has a recall.
  • Of its descendants, K033264 (Medtronic Perfusion Systems, 2003) has gone furthest, with 6 descendants of its own.
  • 3 other devices also cite its predicate K845045.

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.

Indications for use as stated in the FDA summary.

Also cleared against K845045

3 other devices cite the same predicate.

  • K120988DLP Single Stage Venous Cannula, DLP Right Angle Single Stage Venous Cannula, DLP Single Stage Venous…Medtronic, Inc. · 20122 recalls
  • K111972Affinity CP Centrifugal Pump, Resting Heart Sys.,Myotherm Cardioplegia Deliv.,Affinity Hollow Fiber…Medtronic, Inc. · 2011
  • K031827Ultraflex Venous Cannula, Model 970XX and CB970XXMedtronic Perfusion Systems · 2003

More from Medtronic Cardiac Surgical Products

7 FDA decisions under this applicant name. See the company

  • K013013Medtronic DLP Arterial Cannula with 3D Tip - 22 FR.Medtronic Cardiac Surgical Products · 20011 recall
  • K01214324 FR. Left Heart Vent Catheter with Pressure Monitoring Line, Model 12524Medtronic Cardiac Surgical Products · 2001
  • K010737Select Cap Arterial Cannula with Pressure Monitoring Line, Model…Medtronic Cardiac Surgical Products · 20011 recall
  • K000776Medtronic DLP Arterial Cannulae with 3D TipMedtronic Cardiac Surgical Products · 20011 recall
  • K994171Medtronic Aortocoronary Shunt and Separately Packaged Arteriotomy CannulaeMedtronic Cardiac Surgical Products · 2000

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/K022272 · printed Nov 6, 2026

Cite this page

510(k) Report. “K022272: Malleable Single Stage Venous Cannula, Models 68112-68140 (15 Total Codes).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K022272

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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