510(k) · Cleared

Cleared

Fem-Flex II Femoral Arterial Cannula, Fem-Flex II Femoral Venous Cannula, Femoral Venous Cannula, FemTrak Femoral Venous Cannula

K200358510(k) SpecialCleared Mar 13, 202029-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, LLC · DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass

Cleared on Mar 13, 2020 as substantially equivalent to K140208 (Edwards Lifesciences, LLC, 2014) after a 29-day review. Its family tree reaches back 3 generations to 1989. 1 of the 8 devices in its family, counting itself, has a Class I recall.

Decided: Mar 13, 2020
Review: 29 days
Class: Class II
Product code: DWF
Recalls: None
Predicates: 1

Its longest line of descent runs back 3 generations to K891576 (1989). 7 ancestors in all. No later device cites it as a predicate yet. 1 of the 8 devices in this family, counting this one, has a Class I recall.

By dateBy generation

Root · 3 generations backK891576 Fem-Flex Femoral Access Cannulation SetResearch Medical, Inc. · 1989 · Recalled
2 generations backK123298 Fem-Felx, Fex-Flex II Femoral Access Cannula with Duraflo CoatingEdwards Lifesciences, LLC · 2013 · Recalled
1 generation backK140208 Ferm-Flex and Fem-Flex II ( Femoral Access Arterial Cannulae)…Edwards Lifesciences, LLC · 2014 · Recalled (Class I)
This deviceK200358 Fem-Flex II Femoral Arterial Cannula, Fem-Flex II Femoral Venous…Edwards Lifesciences, LLC · 2020

Class I recalls in this family

K140208 Ferm-Flex and Fem-Flex II ( Femoral Access…direct predicate · 2014

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−3	K891576	Fem-Flex Femoral Access Cannulation Set	Research Medical, Inc.	1989	2
−2	K123298	Fem-Felx, Fex-Flex II Femoral Access Cannula with Duraflo Coating	Edwards Lifesciences, LLC	2013	4
−1	K140208	Ferm-Flex and Fem-Flex II ( Femoral Access Arterial Cannulae) Femtrak,Vfem…	Edwards Lifesciences, LLC	2014	Class I
0 (this device)	K200358	Fem-Flex II Femoral Arterial Cannula, Fem-Flex II Femoral Venous Cannula…	Edwards Lifesciences, LLC	2020	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1991	1	0
2004	2	0
2013	1	0

FIG. 1 — Lineage of K200358, 1989–2020Source: 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.

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 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? (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.

Type	Number	Device	Applicant	Decided	Recalls
*	K140208	Ferm-Flex and Fem-Flex II ( Femoral Access Arterial Cannulae) Femtrak,Vfem, and Fem-Flexii Summary page 4 …ing, Vascular, Cardiopulmonary Bypass Classification Name: 21 CFR Part 870.4210, Product Code DWF, Class II Predicate Device: K140208 Femoral Access Venous and Arterial Cannulae The Edwards Femoral Access Venous and Arterial Cannulae…	Edwards Lifesciences, LLC	2014	Class I

What descends from it?

No later submission names this one as a predicate yet.

Has anything in its family been recalled? (1 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.

K140208Ferm-Flex and Fem-Flex II ( Femoral Access Arterial Cannulae) Femtrak,Vfem, and Fem-FlexiiEdwards Lifesciences, LLC · 2014 · Direct predicate · ◆ on the line of descent in FIG. 14 Class I recalls

What does this lineage say?

The line of descent spans 31 years and passes through 2 companies; a new generation was cleared every 6.0 years on median.
5 of the 7 ancestors have a recall of any class; 1 has a Class I 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. 2020, this device’s year, is highlighted.

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?

Edwards Lifesciences Femoral Access Cannulae are intended for use in situations which require rapid femoral venous and arterial access for short-term (≤ 6 hours) cardiopulmonary bypass. Vessel access (venous or arterial) is left to the discretion of the physician.

Femoral access cannulae may be used in pediatric populations or adult populations based on flow rate requirements and individual patient anatomy. Please consult labeling to determine pressure drop related to flow rates.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K200358 · printed Nov 6, 2026

Cite this page

510(k) Report. “K200358: Fem-Flex II Femoral Arterial Cannula, Fem-Flex II Femoral Venous Cannula, Femoral Venous Cannula, FemTrak Femoral Venous Cannula.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K200358

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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