510(k) Report

510(k) · Cleared

Recalled · Class I · 2025

Miar (Minimally Invasive Aortic Root) Cannula with Flow-Guard, Models 11012L and 11014L

K100274510(k) TraditionalCleared May 10, 2010101-day reviewClass II21 CFR 870.4210Recalls 1 (1 Class I)

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

Medtronic, Inc. · DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass

Cleared on May 10, 2010 as substantially equivalent to K790565 (Dlp, Inc., 1979) and 1 other predicate after a 101-day review. Its family tree reaches back 2 generations to 1979. 1 of the 5 devices in its family, counting itself, has a Class I recall. It has been recalled once, including a Class I recall.

Decided
May 10, 2010
Review
101 days
Class
Class II
Product code
DWF
Recalls
1 (1 Class I)
Predicates
2

Its longest line of descent runs back 2 generations to K790565 (1979). 4 ancestors in all. No later device cites it as a predicate yet. 1 of the 5 devices in this family, counting this one, has a Class I recall.

Other ancestors, by year cleared 1983: 1 other ancestor1981: 1 other ancestorK790565 · Aortic Root Cannula · Dlp, Inc. · 1979 · recalledK040173 · Pediatric Aortic Root Cannula · Medtronic Perfusion Systems · 20041980199020002010
Other ancestors, by generation 2 generations back: 2 other ancestors K040173 · Pediatric Aortic Root Cannula · Medtronic Perfusion Systems · 2004K790565 · Aortic Root Cannula · Dlp, Inc. · 1979 · recalled0
  1. Root · 2 generations backK790565 Aortic Root CannulaDlp, Inc. · 1979 · Recalled
  2. 1 generation backK040173 Pediatric Aortic Root CannulaMedtronic Perfusion Systems · 2004
  3. This deviceK100274 Miar (Minimally Invasive Aortic Root) Cannula with Flow-Guard…Medtronic, Inc. · 2010
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−2K790565Aortic Root CannulaDlp, Inc.19791
−1K040173Pediatric Aortic Root CannulaMedtronic Perfusion Systems2004—
0 (this device)K100274Miar (Minimally Invasive Aortic Root) Cannula with Flow-Guard, Models 11012L…Medtronic, Inc.2010—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198110
198310
FIG. 1 — Lineage of K100274, 1979–2010Source: 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.

1 device in this family has a Class I recall. 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
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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.

TypeNumberDeviceApplicantDecidedRecalls
*K790565Aortic Root Cannula
Summary page 1
…catheter, cannula, or tubing Regulation Number: 21 CFR 870.421 0 Product Code: DWF Classification: Class 11 Predicate Devices Medtronic DLP Aortic Root Cannula (K790565) Medtronic Pediatric Aortic Root Cannula (K040 173) Device Description MiARTM Cannulae are single-use, sterile, nonpyrogenic dev…
Dlp, Inc.19791
*K040173Pediatric Aortic Root Cannula
Summary page 1
…CFR 870.421 0 Product Code: DWF Classification: Class 11 Predicate Devices Medtronic DLP Aortic Root Cannula (K790565) Medtronic Pediatric Aortic Root Cannula (K040 173) Device Description MiARTM Cannulae are single-use, sterile, nonpyrogenic devices designed to deliver cardioplegia through the a…
Medtronic Perfusion Systems2004—

Also cleared against K790565: 7 other devices →

What descends from it?

No later submission names this one as a predicate yet.

Has anything in its family been recalled? (1 Class I)

Recalls of this device

DateClassRecallRoot causeReason
Feb 5, 2025Class IZ-1306-2025Process controlUnexpected loose material in the male luer used in the aortic root cannula has been identified. Potential harms when identified prior to use - procedure delay. Potential harm if not identified and used - stroke (reversible and…

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • The line of descent spans 31 years and passes through 3 companies; a new generation was cleared every 24.8 years on median.
  • 2 of the 4 ancestors have a recall of any class.
  • 7 other devices also cite its predicate K790565.

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. 2010, this device’s year, is highlighted.

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?

The MiARTM cannula is intended for use during cardiopulmonary bypass for the delivery of cardiopiegia up to 6 hours. The cannula may also be used to aspirate air from the aorta at the conclusion of the bypass procedure. It is indicated for use during cardiac surgery for median sternotomy or minimally invasive (mini-sternotomy or right thoracotomy) access using direct visualization techniques.

Indications for use as stated in the FDA summary.

Also cleared against K790565

7 other devices cite the same predicate.

  • K111972Affinity CP Centrifugal Pump, Resting Heart Sys.,Myotherm Cardioplegia Deliv.,Affinity Hollow Fiber…Medtronic, Inc. · 2011
  • K040173Pediatric Aortic Root CannulaMedtronic Perfusion Systems · 2004
  • K980631Embol-X Aortic Occlusion and Cardioplegia CannulaEmbol-X, Inc. · 1999
  • K972503Cardioplegia Adapters, Vessel Canulae, and Aortic Root CannulaeSorin Group Italia S.R.L. · 19971 recall
  • K970914Chase Aortic Perfusion CannulaChase Medical, Inc. · 1997
  • K964198Cahse Aortic Root CannulaChase Medical, Inc. · 1997

More from Medtronic, Inc.

6,442 FDA decisions under this applicant name. See the company

  • P220026/S019Symplicity G3 Renal Denervation RF GeneratorMedtronic, Inc. · 2026
  • P240036/S007OmniaSecure™ MRI SureScan™ Lead Model 3930MMedtronic, Inc. · 2026
  • P010015/S591Percepta Bipolar CRT-P (W1TR01); Percepta Quadripolar CRT-P (W4TR01); Serena Bipolar CRT-P (W1TR02); Serena…Medtronic, Inc. · 2026
  • P980035/S848Astra S DR MRI IPG (X3DR01); Astra S SR MRI IPG (X3SR01); Astra XT DR MRI IPG (X1DR01); Astra XT SR MRI IPG…Medtronic, Inc. · 2026
  • P860004/S462SynchroMed™ Infusion System, Ascenda ™ Intrathecal CathetersMedtronic, Inc. · 2026

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/K100274 · printed Nov 6, 2026

Cite this page

510(k) Report. “K100274: Miar (Minimally Invasive Aortic Root) Cannula with Flow-Guard, Models 11012L and 11014L.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K100274

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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