510(k) · Cleared

Recalled · Class II · 2021

Bio-Medicus Insertion Kit

K190557510(k) SpecialCleared Apr 3, 201929-day reviewClass II21 CFR 870.4210Recalls 1

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

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

Cleared on Apr 3, 2019 as substantially equivalent to K150567 (Medtronic, Inc., 2015) after a 29-day review. Its family tree reaches back 2 generations to 1992. It has been recalled once.

Decided: Apr 3, 2019
Review: 29 days
Class: Class II
Product code: DWF
Recalls: 1
Predicates: 1

Its longest line of descent runs back 2 generations to K924643 (1992). No later device cites it as a predicate yet.

By dateBy generation

Root · 2 generations backK924643 Medtronic Bio-Medicus Cannula Insertion KitMedtronic Bio-Medicus, Inc. · 1992
1 generation backK150567 Medtronic Bio-Medicus Cannula Insertion KitMedtronic, Inc. · 2015
This deviceK190557 Bio-Medicus Insertion KitMedtronic, Inc. · 2019

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K924643	Medtronic Bio-Medicus Cannula Insertion Kit	Medtronic Bio-Medicus, Inc.	1992	—
−1	K150567	Medtronic Bio-Medicus Cannula Insertion Kit	Medtronic, Inc.	2015	—
0 (this device)	K190557	Bio-Medicus Insertion Kit	Medtronic, Inc.	2019	—

FIG. 1 — Lineage of K190557, 1992–2019Source: 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
*	K150567	Medtronic Bio-Medicus Cannula Insertion Kit Summary page 4 …Cardiopulmonary Bypass Classification Class II, 21 CFR 870.4210 Product Code DWF Name of Predicate Device Bio-Medicus Insertion Kit (K150567, predicate) Device Description The Bio-Medicus Insertion Kits are used during cardiopu…	Medtronic, Inc.	2015	—

Also cleared against K150567: 1 other device →

What descends from it?

No later submission names this one as a predicate yet.

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

Recalls of this device

Date	Class	Recall	Root cause	Reason
Sep 13, 2021	Class II	Z-0003-2022	Under Investigation by firm	There was a label mix-up between two model numbers resulting in the incorrect guidewire being contained in the kits for both model numbers.

No ancestor or descendant has a Class I recall.

What does this lineage say?

The line of descent spans 27 years and passes through 2 companies; a new generation was cleared every 22.3 years on median.
None of the 2 ancestors has a recall.
1 other device also cites its predicate K150567.

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. 2019, 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?

This kit is intended for use by trained physicians only, to assist in vessel cannulation for cardiopulmonary bypass circulation. Standard surgical or percutaneous insertion techniques can be employed. This kit is intended for use for up to 6 hours.

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/K190557 · printed Nov 6, 2026

Cite this page

510(k) Report. “K190557: Bio-Medicus Insertion Kit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K190557

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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