510(k) · Cleared

Cleared

Venous Flex II Peripheral and Intra-Operative Access Venous Return Cannulae

K974259510(k) TraditionalCleared Dec 1, 1998383-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

Edwards Lifesciences Research Medical · DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass

Cleared on Dec 1, 1998 as substantially equivalent to K831769 (Research Industries Corp., 1983) and 1 other predicate after a 383-day review. Its family tree reaches back 1 generation to 1983. 3 later devices descend from it.

Decided: Dec 1, 1998
Review: 383 days
Class: Class II
Product code: DWF
Recalls: None
Predicates: 2

Its longest line of descent runs back 1 generation to K831769 (1983). 2 ancestors in all. 3 later devices descend from it, 2 citing it directly.

By dateBy generation

Root · 1 generation backK831769 Various Cardiovascular Surgical DeviceResearch Industries Corp. · 1983 · Recalled
This deviceK974259 Venous Flex II Peripheral and Intra-Operative Access Venous Return…Edwards Lifesciences Research Medical · 1998
Descendant · cites it directly · 1 of its ownK091542 Estech Easyflow Cannula with GuidewireEndoscopic Technologies, Inc. D/B/A Estech · 2009
Descendant · 2 generations on · 0 of its ownK250610 Easyflow (103-200; 103-300); Easyflow Duo (103-210; 103-310)Sorin Group Italia S.R.L. · 2025
Descendant · cites it directly · 0 of its ownK991541 A-Med Vascular Cannula, Models V24-10-08, V24-10-16, V24-10-32…A-Med Systems, Inc. · 1999

Most influential descendants

Showing 3 of 3 · See all

K091542Estech Easyflow Cannula with GuidewireEndoscopic Technologies, Inc. D/B/A Estech · 2009 · cites it directly1descendant
K250610Easyflow (103-200; 103-300); Easyflow Duo (103-210; 103-310)Sorin Group Italia S.R.L. · 2025 · 2 generations on0descendants
K991541A-Med Vascular Cannula, Models V24-10-08, V24-10-16, V24-10-32, V24-21-08, V24-21-44A-Med Systems, Inc. · 1999 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K831769	Various Cardiovascular Surgical Device	Research Industries Corp.	1983	8
0 (this device)	K974259	Venous Flex II Peripheral and Intra-Operative Access Venous Return Cannulae	Edwards Lifesciences Research Medical	1998	—
+1	K091542	Estech Easyflow Cannula with Guidewire	Endoscopic Technologies, Inc. D/B/A Estech	2009	—
+2	K250610	Easyflow (103-200; 103-300); Easyflow Duo (103-210; 103-310)	Sorin Group Italia S.R.L.	2025	—
+1	K991541	A-Med Vascular Cannula, Models V24-10-08, V24-10-16, V24-10-32, V24-21-08…	A-Med Systems, Inc.	1999	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1989	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
1999	1	0
2009	1	0
2025	1	0

FIG. 1 — Lineage of K974259, 1983–2025Source: 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.

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 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

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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.

Type	Number	Device	Applicant	Decided	Recalls
*	K831769	Various Cardiovascular Surgical Device Summary page 1 …f the BRMI Venous Flex II Peripheral and Intra- Operative Access Venous Return Cannulae is made to the following Baxter Research Medical, Inc. product family 510(k)s: . K831769, Various Cardiovascular Surgical Devices [Dual Stage and Single Stage Venous Return Catheters . K 891576, FEM-Flex Femoral Acces…	Research Industries Corp.	1983	8
*	K891576	Fem-Flex Femoral Access Cannulation Set Summary page 1 …llowing Baxter Research Medical, Inc. product family 510(k)s: . K831769, Various Cardiovascular Surgical Devices [Dual Stage and Single Stage Venous Return Catheters . K 891576, FEM-Flex Femoral Access Cannulation Set These devices were marketed prior to May 28, 1976 or have received FDA clearance to mar…	Research Medical, Inc.	1989	2

Also cleared against K831769: 3 other devices →

What descends from it? (3)

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

Number	Device	Applicant	Decided	Descendants
K091542	Estech Easyflow Cannula with Guidewire	Endoscopic Technologies, Inc. D/B/A Estech	2009	1
K991541	A-Med Vascular Cannula, Models V24-10-08, V24-10-16, V24-10-32, V24-21-08, V24-21-44	A-Med Systems, Inc.	1999	0

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

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

2 of the 2 ancestors have a recall of any class.
Of its descendants, K091542 (Endoscopic Technologies, Inc. D/B/A Estech, 2009) has gone furthest, with 1 descendant of its own.
3 other devices also cite its predicate K831769.

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?

The BRMI Venous Flex II Peripheral and Intra-Operative Access Venous Return Cannulae, PIFlex-II-xxx-V, are intended far use in situations in which short term cardiopulmonary bypass peripheral access venous return procedures, i.e., internal jugular vein, right innominate vein, and femoral vein access, as well as the standard intra-operative access venous return procedures, i.e., right atrial appendage and right atriotomy access is desired. Venous access is left to the discretion of the physician.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

https://510kreport.com/device/K974259 · printed Nov 4, 2026

Cite this page

510(k) Report. “K974259: Venous Flex II Peripheral and Intra-Operative Access Venous Return Cannulae.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K974259

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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