510(k) · Cleared

Cleared

Duraflo II Heparin Treated Femoral Cannulae Models

K905312510(k) TraditionalCleared Jan 15, 199148-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

Baxter Bentley Laboratories, Inc. · DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass

Cleared on Jan 15, 1991 after a 48-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 1 of the 5 devices in its family, counting itself, has a Class I recall. 4 later devices descend from it.

Decided: Jan 15, 1991
Review: 48 days
Class: Class II
Product code: DWF
Recalls: None
Predicates: 0

4 later devices descend from it, 2 citing it directly. 1 of the 5 devices in this family, counting this one, has a Class I recall.

This deviceK905312 Duraflo II Heparin Treated Femoral Cannulae ModelsBaxter Bentley Laboratories, Inc. · 1991
Descendant · cites it directly · 2 of its ownK123303 Femoral Access Venous CannulaeEdwards Lifesciences, LLC · 2013
Descendant · cites it directly · 2 of its ownK123298 Fem-Felx, Fex-Flex II Femoral Access Cannula with Duraflo CoatingEdwards Lifesciences, LLC · 2013 · Recalled
Descendant · 2 generations on · 1 of its ownK140208 Ferm-Flex and Fem-Flex II ( Femoral Access Arterial Cannulae)…Edwards Lifesciences, LLC · 2014 · Recalled (Class I)
Descendant · 3 generations on · 0 of its ownK200358 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…2 generations on · 2014

Most influential descendants

Showing 4 of 4 · See all

K123303Femoral Access Venous CannulaeEdwards Lifesciences, LLC · 2013 · cites it directly2descendants
K123298Fem-Felx, Fex-Flex II Femoral Access Cannula with Duraflo CoatingEdwards Lifesciences, LLC · 2013 · cites it directly2descendants
K140208Ferm-Flex and Fem-Flex II ( Femoral Access Arterial Cannulae) Femtrak,Vfem, and Fem-FlexiiEdwards Lifesciences, LLC · 2014 · 2 generations on1descendant
K200358Fem-Flex II Femoral Arterial Cannula, Fem-Flex II Femoral Venous Cannula, Femoral Venous…Edwards Lifesciences, LLC · 2020 · 3 generations on0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K905312	Duraflo II Heparin Treated Femoral Cannulae Models	Baxter Bentley Laboratories, Inc.	1991	—
+1	K123303	Femoral Access Venous Cannulae	Edwards Lifesciences, LLC	2013	—
+1	K123298	Fem-Felx, Fex-Flex II Femoral Access Cannula with Duraflo Coating	Edwards Lifesciences, LLC	2013	4
+2	K140208	Ferm-Flex and Fem-Flex II ( Femoral Access Arterial Cannulae) Femtrak,Vfem…	Edwards Lifesciences, LLC	2014	Class I
+3	K200358	Fem-Flex II Femoral Arterial Cannula, Fem-Flex II Femoral Venous Cannula…	Edwards Lifesciences, LLC	2020	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2013	2	0
2014	1	1
2020	1	0

FIG. 1 — Lineage of K905312, 1991–2020Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), 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?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (4)

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

Number	Device	Applicant	Decided	Descendants
K123303	Femoral Access Venous Cannulae	Edwards Lifesciences, LLC	2013	2
K123298	Fem-Felx, Fex-Flex II Femoral Access Cannula with Duraflo Coating	Edwards Lifesciences, LLC	2013	2

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 · 2 generations on · ◆ in the 2014 descendants bar of FIG. 14 Class I recalls

What does this lineage say?

Of its descendants, K123303 (Edwards Lifesciences, LLC, 2013) has gone furthest, with 2 descendants of its own.

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	—

https://510kreport.com/device/K905312 · printed Nov 6, 2026

Cite this page

510(k) Report. “K905312: Duraflo II Heparin Treated Femoral Cannulae Models.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K905312

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Record history

FDA decision record loaded May 2, 2026
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026