510(k) Report

510(k) · Cleared

Recalled · 2008

Tenderflow Periatric Arterial Cannula

K063618510(k) SpecialCleared Mar 13, 200798-day reviewClass II21 CFR 870.4210Recalls 24

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

Terumo Cardiovascular Systems Corp. · DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass

Cleared on Mar 13, 2007 as substantially equivalent to K930620 (C.R. Bard, Inc., 1993) after a 98-day review. Its family tree reaches back 1 generation to 1993. It has been recalled 24 times.

Decided
Mar 13, 2007
Review
98 days
Class
Class II
Product code
DWF
Recalls
24
Predicates
1

Its longest line of descent runs back 1 generation to K930620 (1993). No later device cites it as a predicate yet.

K930620 · Bard (R) William Harvey (R) Arterial Straigh Cannula · C.R. Bard, Inc. · 1993 · recalled1990199520002005
K930620 · Bard (R) William Harvey (R) Arterial Straigh Cannula · C.R. Bard, Inc. · 1993 · recalled0
  1. Root · 1 generation backK930620 Bard (R) William Harvey (R) Arterial Straigh CannulaC.R. Bard, Inc. · 1993 · Recalled
  2. This deviceK063618 Tenderflow Periatric Arterial CannulaTerumo Cardiovascular Systems Corp. · 2007
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K930620Bard (R) William Harvey (R) Arterial Straigh CannulaC.R. Bard, Inc.19932
0 (this device)K063618Tenderflow Periatric Arterial CannulaTerumo Cardiovascular Systems Corp.2007—
FIG. 1 — Lineage of K063618, 1993–2007Source: 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
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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
*K930620Bard (R) William Harvey (R) Arterial Straigh Cannula
Summary page 1
…fied as Class II devices Predicate Device: The unmodified device is identified as Terumo's L Series 1863 Arterial Cannula. This device was originally cleared by FDA with K930620, dated May 8, 1993. This device is legally marketed and has not been the subject of Premarket Notification 510(k) clearance. The…
C.R. Bard, Inc.19932

What descends from it?

No later submission names this one as a predicate yet.

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

Recalls of this device

DateClassRecallRoot causeReason
Oct 16, 2008Not classifiedZ-0637-2009Device DesignThe introducer or stylet is difficult to remove from the pediatric arterial cannula body, which may result in the need to remove the cannula and replace it.
Oct 16, 2008Not classifiedZ-0638-2009Device DesignThe introducer or stylet is difficult to remove from the pediatric arterial cannula body, which may result in the need to remove the cannula and replace it.
Oct 16, 2008Not classifiedZ-0639-2009Device DesignThe introducer or stylet is difficult to remove from the pediatric arterial cannula body, which may result in the need to remove the cannula and replace it.
Oct 16, 2008Not classifiedZ-0640-2009Device DesignThe introducer or stylet is difficult to remove from the pediatric arterial cannula body, which may result in the need to remove the cannula and replace it.
Oct 16, 2008Not classifiedZ-0630-2009Device DesignThe introducer or stylet is difficult to remove from the pediatric arterial cannula body, which may result in the need to remove the cannula and replace it.
Oct 16, 2008Not classifiedZ-0633-2009Device DesignThe introducer or stylet is difficult to remove from the pediatric arterial cannula body, which may result in the need to remove the cannula and replace it.
Oct 16, 2008Not classifiedZ-0634-2009Device DesignThe introducer or stylet is difficult to remove from the pediatric arterial cannula body, which may result in the need to remove the cannula and replace it.
Oct 16, 2008Not classifiedZ-0636-2009Device DesignThe introducer or stylet is difficult to remove from the pediatric arterial cannula body, which may result in the need to remove the cannula and replace it.
Oct 16, 2008Not classifiedZ-0641-2009Device DesignThe introducer or stylet is difficult to remove from the pediatric arterial cannula body, which may result in the need to remove the cannula and replace it.
Oct 16, 2008Not classifiedZ-0631-2009Device DesignThe introducer or stylet is difficult to remove from the pediatric arterial cannula body, which may result in the need to remove the cannula and replace it.
Oct 16, 2008Not classifiedZ-0632-2009Device DesignThe introducer or stylet is difficult to remove from the pediatric arterial cannula body, which may result in the need to remove the cannula and replace it.
Oct 16, 2008Not classifiedZ-0635-2009Device DesignThe introducer or stylet is difficult to remove from the pediatric arterial cannula body, which may result in the need to remove the cannula and replace it.
May 22, 2007Not classifiedZ-0877-2007OtherThe bond may fail and a leak or separation of the device occur at the distal end (where this device connects to the arterial line).
May 22, 2007Not classifiedZ-0881-2007OtherThe bond may fail and a leak or separation of the device occur at the distal end (where this device connects to the arterial line).
May 22, 2007Not classifiedZ-0879-2007OtherThe bond may fail and a leak or separation of the device occur at the distal end (where this device connects to the arterial line).
May 22, 2007Not classifiedZ-0880-2007OtherThe bond may fail and a leak or separation of the device occur at the distal end (where this device connects to the arterial line).
May 22, 2007Not classifiedZ-0883-2007OtherThe bond may fail and a leak or separation of the device occur at the distal end (where this device connects to the arterial line).
May 22, 2007Not classifiedZ-0885-2007OtherThe bond may fail and a leak or separation of the device occur at the distal end (where this device connects to the arterial line).
May 22, 2007Not classifiedZ-0874-2007OtherThe bond may fail and a leak or separation of the device occur at the distal end (where this device connects to the arterial line).
May 22, 2007Not classifiedZ-0876-2007OtherThe bond may fail and a leak or separation of the device occur at the distal end (where this device connects to the arterial line).
May 22, 2007Not classifiedZ-0878-2007OtherThe bond may fail and a leak or separation of the device occur at the distal end (where this device connects to the arterial line).
May 22, 2007Not classifiedZ-0884-2007OtherThe bond may fail and a leak or separation of the device occur at the distal end (where this device connects to the arterial line).
May 22, 2007Not classifiedZ-0875-2007OtherThe bond may fail and a leak or separation of the device occur at the distal end (where this device connects to the arterial line).
May 22, 2007Not classifiedZ-0882-2007OtherThe bond may fail and a leak or separation of the device occur at the distal end (where this device connects to the arterial line).

The 5 latest of 24 recalls; the web page lists all.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Its one ancestor has a recall.

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. 2007, 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 TenderFlowTM Pediatric Arterial Cannula is a surgically invasive device

intended for short term use and indicated for cannulation and perfusion of the

ascending aorta during cardiopulmonary bypass surgery.

These devices are indicated for up to 6 hours of use.

Indications for use as stated in the FDA summary.

More from Terumo Cardiovascular Systems Corp.

43 FDA decisions under this applicant name. See the company

  • K153140Terumo Capiox SX18 Oxygenator/ Hardshell Reservoir, Terumo Capiox SX18 Oxygenator/ Hardshell Reservoir with…Terumo Cardiovascular Systems Corp. · 2015
  • K133658Cdi Blood Parameter Monitoring System 500Terumo Cardiovascular Systems Corp. · 20144 recalls
  • K131041Advanced Perfusion System 1Terumo Cardiovascular Systems Corp. · 2014
  • K132451Sarns Soft-Flow Aortic CannulaTerumo Cardiovascular Systems Corp. · 2014
  • K133151Sarns High Flow Aortic Arch CannulaTerumo Cardiovascular Systems Corp. · 2014

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/K063618 · printed Nov 4, 2026

Cite this page

510(k) Report. “K063618: Tenderflow Periatric Arterial Cannula.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K063618

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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