510(k) · Cleared

Recalled · Class II · 2016

Tubing and Connectors with Trillium Biopassive Surface

K012538510(k) SpecialCleared Aug 23, 200116-day reviewClass II21 CFR 870.4210Recalls 5

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

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

Cleared on Aug 23, 2001 as substantially equivalent to K800178 (Extracorporeal Medical Specialities, Inc., 1980) after a 16-day review. Its family tree reaches back 1 generation to 1980. 14 later devices descend from it. It has been recalled 5 times.

Decided: Aug 23, 2001
Review: 16 days
Class: Class II
Product code: DWF
Recalls: 5
Predicates: 1

Its longest line of descent runs back 1 generation to K800178 (1980). 14 later devices descend from it, 2 citing it directly.

By dateBy generation

Root · 1 generation backK800178 Extracorp.'S Intersept Cus. Tubing PK.Extracorporeal Medical Specialities, Inc. · 1980 · Recalled
This deviceK012538 Tubing and Connectors with Trillium Biopassive SurfaceMedtronic Vascular · 2001
Descendant · cites it directly · 7 of its ownK113845 Tubing, Conmnectors, and Accessories Wit Balance BiosurfaceMedtronic, Inc. · 2012 · Recalled
Descendant · 2 generations on · 5 of its ownK122811 Connector Components with Balance BiosurfaceMedtronic, Inc. · 2012 · Recalled
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 ownK151523 Uncoated Tubing and Connector ComponentsMedtronic, Inc. · 2015
Descendant · 2 generations on · 4 of its ownK120988 DLP Single Stage Venous Cannula, DLP Right Angle Single Stage Venous…Medtronic, Inc. · 2012 · Recalled

Showing 5 of 14 descendants. See all descendants

Descendants cleared per year

2011high 4 (2012) · low 0 (2013)2026

Most influential descendants

Showing 5 of 14 · See all

K113845Tubing, Conmnectors, and Accessories Wit Balance BiosurfaceMedtronic, Inc. · 2012 · cites it directly7descendants
K122811Connector Components with Balance BiosurfaceMedtronic, Inc. · 2012 · 2 generations on5descendants
K111972Affinity CP Centrifugal Pump, Resting Heart Sys.,Myotherm Cardioplegia Deliv.,Affinity…Medtronic, Inc. · 2011 · cites it directly5descendants
K151523Uncoated Tubing and Connector ComponentsMedtronic, Inc. · 2015 · 2 generations on4descendants
K120988DLP Single Stage Venous Cannula, DLP Right Angle Single Stage Venous Cannula, DLP Single…Medtronic, Inc. · 2012 · 2 generations on4descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K800178	Extracorp.'S Intersept Cus. Tubing PK.	Extracorporeal Medical Specialities, Inc.	1980	10
0 (this device)	K012538	Tubing and Connectors with Trillium Biopassive Surface	Medtronic Vascular	2001	—
+1	K113845	Tubing, Conmnectors, and Accessories Wit Balance Biosurface	Medtronic, Inc.	2012	1
+2	K122811	Connector Components with Balance Biosurface	Medtronic, Inc.	2012	1
+1	K111972	Affinity CP Centrifugal Pump, Resting Heart Sys.,Myotherm Cardioplegia…	Medtronic, Inc.	2011	—
+2	K151523	Uncoated Tubing and Connector Components	Medtronic, Inc.	2015	—
+2	K120988	DLP Single Stage Venous Cannula, DLP Right Angle Single Stage Venous Cannula…	Medtronic, Inc.	2012	2

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2011	1	0
2012	4	0
2014	1	0
2015	1	0
2017	2	0
2022	1	0
2025	1	0
2026	3	0

FIG. 1 — Lineage of K012538, 1980–2026Source: 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

Get a 510(k) Report

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
*	K800178	Extracorp.'S Intersept Cus. Tubing PK. Summary page 1 …ger, Regulatory Affairs Device Name Tubing and Connectors with Trillium™ Biopassive Surface Name of Predicated or Legally Marketed Device Intersept Blood Tubing Packs (K800178) Affinity Hollow Fiber Oxygenator with Trillium™ Biopassive Surface (K973760) Description of Device The tubing consists of bioco…	Extracorporeal Medical Specialities, Inc.	1980	10
†	K973760	Affinity Hollow Fiber Oxygenator with Trillium Biopassive Surface	Avecor Cardiovascular, Inc.	1998	2

Also cleared against K800178: 2 other devices →

What descends from it? (14)

See all 14

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

Number	Device	Applicant	Decided	Descendants
K113845	Tubing, Conmnectors, and Accessories Wit Balance Biosurface	Medtronic, Inc.	2012	7
K111972	Affinity CP Centrifugal Pump, Resting Heart Sys.,Myotherm Cardioplegia Deliv.,Affinity…	Medtronic, Inc.	2011	5

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

Recalls of this device

Date	Class	Recall	Root cause	Reason
Feb 4, 2016	Class III	Z-1023-2016	Component design/selection	Medtronic is notifying customers who have or may receive specific lots of Medtronic Perfusion Tubing Packs that include the potentially affected cuvettes manufactured by Terumo Cardiovascular Systems (Terumo CVS). Terumo Cardiovascular…
Oct 28, 2015	Class II	Z-0268-2016	Packaging process control	This recall is being initiated due to a potential breach of the Tubing Pack Header Bags manufactured in these select lots. The seal in question is between the Tyvek and the Poly side of the header bag.
Aug 18, 2015	Class II	Z-2736-2015	Nonconforming Material/Component	Hemocor High Performance Hemoconcentrators demonstrate low ultrafiltration performance that is below product specification. These potentially affected units have been distributed as stand-alone devices and in specific lots of Medtronic…
Jul 17, 2013	Class II	Z-2106-2013	Process control	Medtronic was notified that Edwards Lifesciences has initiated a product recall for the Rigid Suction Wand, model S099B. The Wands are included within certain Perfusion Tubing Packs that are manufactured and distributed by Medtronic.
Nov 19, 2012	Class II	Z-0618-2013	Package design/selection	Medtronic is initiating an Urgent Medical Device Customer Notification. We have confirmed that certain Medtronic Intersept Tubing Packs contain packaging trays that are susceptible to damage that can compromise product sterility.

No ancestor or descendant has a Class I recall.

What does this lineage say?

Its one ancestor has a recall.
Of its descendants, K113845 (Medtronic, Inc., 2012) has gone furthest, with 7 descendants of its own.
2 other devices also cite its predicate K800178.

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?

This product is indicated for use in the extracorporeal circuit during cardiopulmonary bypass surgery.

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/K012538 · printed Nov 6, 2026

Cite this page

510(k) Report. “K012538: Tubing and Connectors with Trillium Biopassive Surface.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K012538

Report an extraction error

Are you the manufacturer?

Record history

FDA decision record loaded May 2, 2026
Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026