510(k) · Cleared

Cleared

Bio-Medicus Multi-Stage Venous Femoral Percutaneous Kit

K052524510(k) SpecialCleared Nov 22, 200569-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 Nov 22, 2005 as substantially equivalent to K884129 (Bio Medicus, Inc., 1988) after a 69-day review. Its family tree reaches back 1 generation to 1988. 8 later devices descend from it.

Decided: Nov 22, 2005
Review: 69 days
Class: Class II
Product code: DWF
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K884129 (1988). 8 later devices descend from it, 3 citing it directly.

By dateBy generation

Root · 1 generation backK884129 Bio-Medicus Percutaneous Cannula & Introducer SetBio Medicus, Inc. · 1988 · Recalled
This deviceK052524 Bio-Medicus Multi-Stage Venous Femoral Percutaneous KitMedtronic Perfusion Systems · 2005
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 · 2 of its ownK140165 MC2 Two-Stage Venous Cannula, Oval MC2 Two-Stage Venous Cannula…Medtronic, Inc. · 2014
Descendant · 4 generations on · 1 of its ownK251258 MC2™ Two-Stage Venous Cannula; MC2X™ Three-Stage Venous CannulaMedtronic, Inc. · 2025
Descendant · 5 generations on · 0 of its ownK262052 Tri Stage Venous CannulaeSorin Group Italia S.R.L. · 2026

Showing 5 of 8 descendants. See all descendants

Descendants cleared per year

2008high 2 (2011) · low 0 (2009)2026

Most influential descendants

Showing 5 of 8 · See all

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
K140165MC2 Two-Stage Venous Cannula, Oval MC2 Two-Stage Venous Cannula, Thin Wall Two-Stage…Medtronic, Inc. · 2014 · 3 generations on2descendants
K251258MC2™ Two-Stage Venous Cannula; MC2X™ Three-Stage Venous CannulaMedtronic, Inc. · 2025 · 4 generations on1descendant
K262052Tri Stage Venous CannulaeSorin Group Italia S.R.L. · 2026 · 5 generations on0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K884129	Bio-Medicus Percutaneous Cannula & Introducer Set	Bio Medicus, Inc.	1988	1
0 (this device)	K052524	Bio-Medicus Multi-Stage Venous Femoral Percutaneous Kit	Medtronic Perfusion Systems	2005	—
+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	K140165	MC2 Two-Stage Venous Cannula, Oval MC2 Two-Stage Venous Cannula, Thin Wall…	Medtronic, Inc.	2014	—
+4	K251258	MC2™ Two-Stage Venous Cannula; MC2X™ Three-Stage Venous Cannula	Medtronic, Inc.	2025	—
+5	K262052	Tri Stage Venous Cannulae	Sorin Group Italia S.R.L.	2026	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2008	1	0
2011	2	0
2012	1	0
2014	1	0
2025	1	0
2026	2	0

FIG. 1 — Lineage of K052524, 1988–2026Source: 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.

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
*	K884129	Bio-Medicus Percutaneous Cannula & Introducer Set Summary page 1 …eous Cannula and Introducer Set Classification: Class II Predicate Devices: Bio-Medicus Femoral Cannula and Introducer K884129 Device Description The Biomedicus Femoral Cannula and Introducer Set include the new Bio-Medicus Femoral Venous…	Bio Medicus, Inc.	1988	1

Also cleared against K884129: 2 other devices →

What descends from it? (8)

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

Number	Device	Applicant	Decided	Descendants
K111972	Affinity CP Centrifugal Pump, Resting Heart Sys.,Myotherm Cardioplegia Deliv.,Affinity…	Medtronic, Inc.	2011	5
K112565	Novaport One Vascular Access Cannula	Novalung GmbH	2011	0
K081933	Avalon Elite Multi-Port Venous Femoral Catheter, 20FR, 22FR, 24FR, 26FR, 28FR	Avalon Laboratories, LLC	2008	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, K111972 (Medtronic, Inc., 2011) has gone furthest, with 5 descendants of its own.
2 other devices also cite its predicate K884129.

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 percutaneous cannula is for use by trained physicians only, to cannulate vessels, perfuse vessels or organs in a patient for cardiopulmonary bypass circulation. Standard surgical or percutaneous insertion techniques can be employed.

This product is intended for use up to six hours or less

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K052524 · printed Nov 6, 2026

Cite this page

510(k) Report. “K052524: Bio-Medicus Multi-Stage Venous Femoral Percutaneous Kit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K052524

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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