510(k) · Cleared

Cleared

Ultraflex Venous Cannula, Model 970XX and CB970XX

K031827510(k) SpecialCleared Jul 2, 200319-day reviewClass II21 CFR 870.4210

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 Jul 2, 2003 as substantially equivalent to K845045 (Dlp, Inc., 1985) and 2 other predicates after a 19-day review. Its family tree reaches back 1 generation to 1985. 2 of the 19 devices in its family, counting itself, have a Class I recall. 15 later devices descend from it.

Decided: Jul 2, 2003
Review: 19 days
Class: Class II
Product code: DWF
Recalls: None
Predicates: 3

Its longest line of descent runs back 1 generation to K845045 (1985). 3 ancestors in all. 15 later devices descend from it, 2 citing it directly. 2 of the 19 devices in this family, counting this one, have a Class I recall.

By dateBy generation

Root · 1 generation backK845045 Venous Return Catheter SS-1Dlp, Inc. · 1985 · Recalled
This deviceK031827 Ultraflex Venous Cannula, Model 970XX and CB970XXMedtronic Perfusion Systems · 2003
Descendant · cites it directly · 8 of its ownK052081 Remote Access Perfusion (Rap) Femoral Venous CannulaEstech, Inc. · 2005 · Recalled
Descendant · 2 generations on · 6 of its ownK060101 Estech Aortic Easy Flow CannulaEndoscopic Technologies, Inc. · 2006
Descendant · cites it directly · 5 of its ownK111972 Affinity CP Centrifugal Pump, Resting Heart Sys.,Myotherm…Medtronic, Inc. · 2011
Descendant · 2 generations on · 4 of its ownK120988 DLP Single Stage Venous Cannula, DLP Right Angle Single Stage Venous…Medtronic, Inc. · 2012 · Recalled
Descendant · 3 generations on · 3 of its ownK083111 Impella 5.0 Catheter FamilyAbiomed, Inc. · 2009 · Recalled

Showing 5 of 15 descendants. See all descendants

Descendants cleared per year

2005high 3 (2025) · low 0 (2007)2026

Class I recalls in this family

K102726 Cardiohelp System4 generations on · 2011
K133598 Cardiohelp System5 generations on · 2014

Most influential descendants

Showing 5 of 15 · See all

K052081Remote Access Perfusion (Rap) Femoral Venous CannulaEstech, Inc. · 2005 · cites it directly8descendants
K060101Estech Aortic Easy Flow CannulaEndoscopic Technologies, Inc. · 2006 · 2 generations on6descendants
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
K083111Impella 5.0 Catheter FamilyAbiomed, Inc. · 2009 · 3 generations on3descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K845045	Venous Return Catheter SS-1	Dlp, Inc.	1985	3
0 (this device)	K031827	Ultraflex Venous Cannula, Model 970XX and CB970XX	Medtronic Perfusion Systems	2003	—
+1	K052081	Remote Access Perfusion (Rap) Femoral Venous Cannula	Estech, Inc.	2005	1
+2	K060101	Estech Aortic Easy Flow Cannula	Endoscopic Technologies, Inc.	2006	—
+1	K111972	Affinity CP Centrifugal Pump, Resting Heart Sys.,Myotherm Cardioplegia…	Medtronic, Inc.	2011	—
+2	K120988	DLP Single Stage Venous Cannula, DLP Right Angle Single Stage Venous Cannula…	Medtronic, Inc.	2012	2
+3	K083111	Impella 5.0 Catheter Family	Abiomed, Inc.	2009	1

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1989	1	0
1993	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2005	1	0
2006	1	0
2009	2	0
2011	2	1
2012	1	0
2013	1	0
2014	2	1
2025	3	0
2026	2	0

FIG. 1 — Lineage of K031827, 1985–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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.

2 devices in this family have 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 K251258 MC2™ Two-Stage Venous Cannula; MC2X™…score 14.6 · 8 generations · no Class I recall
#2 Held for the reportin the report
#3 Held for the reportin the report

Get a 510(k) Report

What was it cleared against? (3)

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.

Type	Number	Device	Applicant	Decided	Recalls
*	K845045	Venous Return Catheter SS-1 Summary page 1 …r catheter, cannula or tubing Classification: Class I1 Predicate Devices: VC28 Venous Cannula K845045 Bio-Medicus8 Femoral Cannula and Introducer K924642…	Dlp, Inc.	1985	3
*	K924642	Medtronic Bio-Medicus Femoral Cannula/Introducer Summary page 1 …cate Devices: VC28 Venous Cannula K845045 Bio-Medicus8 Femoral Cannula and Introducer K924642 Extracorporeal Circuit with Bio-Active Surface K8918687 De…	Medtronic Bio-Medicus, Inc.	1993	1
*	K891687	Extracorporeal Circuit with Bio-Active Surface	Medtronic Blood Systems, Inc.	1989	10

Also cleared against K845045: 3 other devices →

What descends from it? (15)

See all 15

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

Number	Device	Applicant	Decided	Descendants
K052081	Remote Access Perfusion (Rap) Femoral Venous Cannula	Estech, Inc.	2005	8
K111972	Affinity CP Centrifugal Pump, Resting Heart Sys.,Myotherm Cardioplegia Deliv.,Affinity…	Medtronic, Inc.	2011	5

Has anything in its family been recalled? (2 Class I)

No FDA recall names this device.

Relatives with a Class I recall

Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.

K102726Cardiohelp SystemMaquet Cardiopulmonary, AG · 2011 · 4 generations on · ◆ in the 2011 descendants bar of FIG. 11 Class I recall
K133598Cardiohelp SystemMaquet Cardiopulmonary, AG · 2014 · 5 generations on · ◆ in the 2014 descendants bar of FIG. 11 Class I recall

What does this lineage say?

3 of the 3 ancestors have a recall of any class.
Of its descendants, K052081 (Estech, Inc., 2005) has gone furthest, with 8 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

2007high 14 (2014) · low 2 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · DWF

89in 2025

2007high 358 (2021) · low 29 (2024)2026

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

Recalls per year · DWF

4in 2024

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

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

Year	Decisions	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	2	—	25	121
2008	6	95	25	126
2009	8	148	21	99
2010	3	62	26	197
2011	5	85	13	212
2012	10	110	37	233
2013	9	110	14 (1)	238
2014	14	110	6	325
2015	9	46	3 (1)	218
2016	3	32	3	144
2017	5	127	2 (1)	101
2018	5	30	10	118
2019	3	120	2	179
2020	3	30	0	142
2021	5	358	3	162
2022	2	—	0	276
2023	2	—	0	470
2024	3	29	4	401
2025	4	89	0	1,020
2026	8	81	20	—

What is it indicated for?

These cannulae are intended for use in venous drainage via the right atrium and inferior vena cava simultaneously during cardiopulmonary bypass surgery.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K031827 · printed Nov 6, 2026

Cite this page

510(k) Report. “K031827: Ultraflex Venous Cannula, Model 970XX and CB970XX.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K031827

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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