510(k) · Cleared

Cleared

Tandemheart Femoral Venous Cannula Set

K133236510(k) TraditionalCleared Jan 29, 2014100-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

Cardiacassist, Inc. · DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass

Cleared on Jan 29, 2014 as substantially equivalent to K924642 (Medtronic Bio-Medicus, Inc., 1993) after a 100-day review. Its family tree reaches back 1 generation to 1993. 8 later devices descend from it.

Decided: Jan 29, 2014
Review: 100 days
Class: Class II
Product code: DWF
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K924642 (1993). 8 later devices descend from it, 2 citing it directly.

By dateBy generation

Root · 1 generation backK924642 Medtronic Bio-Medicus Femoral Cannula/IntroducerMedtronic Bio-Medicus, Inc. · 1993 · Recalled
This deviceK133236 Tandemheart Femoral Venous Cannula SetCardiacassist, Inc. · 2014
Descendant · cites it directly · 7 of its ownK140999 Tandemheart Veno-Venous CannulaCardiacassist, Inc. · 2014
Descendant · 2 generations on · 5 of its ownK160257 PROTEK Duo 31 Fr. Veno-Venous Cannula SetCardiacassist, Inc. · 2016 · Recalled
Descendant · 3 generations on · 2 of its ownK203067 Quantum Perfusion Single Lumen Cannula 22F, Quantum Perfusion Dual…Qura S.R.L · 2021
Descendant · 4 generations on · 1 of its ownK221353 Quantum Perfusion Dual Lumen Cannula 31F, Quantum Perfusion Dual…Qura S.R.L · 2022
Descendant · 3 generations on · 1 of its ownK181150 ProtekDuo Mini Veno-Venous Cannula SetCardiacassist, Inc. · 2018

Showing 5 of 8 descendants. See all descendants

Descendants cleared per year

2014high 2 (2016) · low 0 (2015)2026

Most influential descendants

Showing 5 of 8 · See all

K140999Tandemheart Veno-Venous CannulaCardiacassist, Inc. · 2014 · cites it directly7descendants
K160257PROTEK Duo 31 Fr. Veno-Venous Cannula SetCardiacassist, Inc. · 2016 · 2 generations on5descendants
K203067Quantum Perfusion Single Lumen Cannula 22F, Quantum Perfusion Dual Lumen Cannula 31F…Qura S.R.L · 2021 · 3 generations on2descendants
K221353Quantum Perfusion Dual Lumen Cannula 31F, Quantum Perfusion Dual Lumen Cannula 27F…Qura S.R.L · 2022 · 4 generations on1descendant
K181150ProtekDuo Mini Veno-Venous Cannula SetCardiacassist, Inc. · 2018 · 3 generations on1descendant

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K924642	Medtronic Bio-Medicus Femoral Cannula/Introducer	Medtronic Bio-Medicus, Inc.	1993	1
0 (this device)	K133236	Tandemheart Femoral Venous Cannula Set	Cardiacassist, Inc.	2014	—
+1	K140999	Tandemheart Veno-Venous Cannula	Cardiacassist, Inc.	2014	—
+2	K160257	PROTEK Duo 31 Fr. Veno-Venous Cannula Set	Cardiacassist, Inc.	2016	1
+3	K203067	Quantum Perfusion Single Lumen Cannula 22F, Quantum Perfusion Dual Lumen…	Qura S.R.L	2021	—
+4	K221353	Quantum Perfusion Dual Lumen Cannula 31F, Quantum Perfusion Dual Lumen Cannula…	Qura S.R.L	2022	—
+3	K181150	ProtekDuo Mini Veno-Venous Cannula Set	Cardiacassist, Inc.	2018	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2014	1	0
2016	2	0
2018	1	0
2021	1	0
2022	1	0
2023	1	0
2024	1	0

FIG. 1 — Lineage of K133236, 1993–2024Source: 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? (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
*	K924642	Medtronic Bio-Medicus Femoral Cannula/Introducer Summary page 1 …r, cannula, or tubing. (21 CFR 870.42 10, Product Code DWF) Predicate Device Medtronic Blo-Medicus Femoral Venous Cannula and Introducer (K924642). The dilator is identical to that used with the Tanderni-leart Transseptal Cannula (K052570 and K082425). Device Desc…	Medtronic Bio-Medicus, Inc.	1993	1
†	K052570	Tandemheart Transseptal Cannula Set-EF, Model 5140-6221	Cardiacassist, Inc.	2006	1
†	K082425	Tandemheart Transseptal Cannula- EF 72	Cardiacassist, Inc.	2008	—

Also cleared against K924642: 9 other devices →

What descends from it? (8)

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

Number	Device	Applicant	Decided	Descendants
K140999	Tandemheart Veno-Venous Cannula	Cardiacassist, Inc.	2014	7
K162214	Protek Solo 24 Fr Venous Cannula Set	Cardiacassist, Inc.	2016	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?

Its one ancestor has a recall.
Of its descendants, K140999 (Cardiacassist, Inc., 2014) has gone furthest, with 7 descendants of its own.
9 other devices also cite its predicate K924642.

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. 2014, 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?

The TandemHeart Venous Cannula Set is intended to cannulate vessels, perfuse vessels or organs and/or connect with accessory extracorporeal circulatory support equipment. The cannula obturator and dilator are intended to facilitate proper insertion and placement of the cannula within the vessel for extracorporeal circulatory support.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K133236 · printed Nov 6, 2026

Cite this page

510(k) Report. “K133236: Tandemheart Femoral Venous Cannula Set.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K133236

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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