510(k) Report

510(k) · Cleared

Recalled · Class II · 2018

Trillium Affinity NT Cardiotomy Venous Reservoir, Models 540T, 541TT

K021287510(k) SpecialCleared May 7, 200214-day reviewClass II21 CFR 870.4400Recalls 1

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

Medtronic Perfusion Systems · DTN Reservoir, Blood, Cardiopulmonary Bypass

Cleared on May 7, 2002 as substantially equivalent to K936003 (Avecor Cardiovascular, Inc., 1994) after a 14-day review. Its family tree reaches back 1 generation to 1994. 11 later devices descend from it. It has been recalled once.

Decided
May 7, 2002
Review
14 days
Class
Class II
Product code
DTN
Recalls
1
Predicates
1

Its longest line of descent runs back 1 generation to K936003 (1994). 11 later devices descend from it, 2 citing it directly.

Descendants, by year cleared 2012: 3 descendants cleared2011: 1 descendant cleared2014: 2 descendants cleared2017: 1 descendant cleared2016: 1 descendant cleared2026: 2 descendants cleared2025: 1 descendant clearedReference device: K973760 · Affinity Hollow Fiber Oxygenator with Trillium Biopassive Surface · Avecor Cardiovascular, Inc. · 1998 · recalledK936003 · Affinity CVR · Avecor Cardiovascular, Inc. · 1994 · recalled1990200020102020
Descendants, by generation 1 generation forward: 2 descendants2 generations forward: 5 descendants3 generations forward: 2 descendants4 generations forward: 1 descendant5 generations forward: 1 descendant K936003 · Affinity CVR · Avecor Cardiovascular, Inc. · 1994 · recalled0+5
  1. Root · 1 generation backK936003 Affinity CVRAvecor Cardiovascular, Inc. · 1994 · Recalled
  2. This deviceK021287 Trillium Affinity NT Cardiotomy Venous Reservoir, Models 540T, 541TTMedtronic Perfusion Systems · 2002
  3. Descendant · cites it directly · 5 of its ownK111972 Affinity CP Centrifugal Pump, Resting Heart Sys.,Myotherm…Medtronic, Inc. · 2011
  4. Descendant · cites it directly · 4 of its ownK100645 Affinity Pixie Oxygenation System with Carmeda Bioactive Surface or…Medtronic, Inc. · 2012
  5. Descendant · 2 generations on · 4 of its ownK120988 DLP Single Stage Venous Cannula, DLP Right Angle Single Stage Venous…Medtronic, Inc. · 2012 · Recalled
  6. Descendant · 3 generations on · 2 of its ownK140165 MC2 Two-Stage Venous Cannula, Oval MC2 Two-Stage Venous Cannula…Medtronic, Inc. · 2014
  7. Descendant · 4 generations on · 1 of its ownK251258 MC2™ Two-Stage Venous Cannula; MC2X™ Three-Stage Venous CannulaMedtronic, Inc. · 2025

Showing 5 of 11 descendants. See all descendants

Descendants cleared per year

2011: 12012: 32014: 22016: 12017: 12025: 12026: 2
2011high 3 (2012) · low 0 (2013)2026

Most influential descendants

Showing 5 of 11 · See all
  • K111972Affinity CP Centrifugal Pump, Resting Heart Sys.,Myotherm Cardioplegia Deliv.,Affinity…Medtronic, Inc. · 2011 · cites it directly5descendants
  • K100645Affinity Pixie Oxygenation System with Carmeda Bioactive Surface or Balance BiosurfaceMedtronic, Inc. · 2012 · cites it directly4descendants
  • 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
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K936003Affinity CVRAvecor Cardiovascular, Inc.19943
0 (this device)K021287Trillium Affinity NT Cardiotomy Venous Reservoir, Models 540T, 541TTMedtronic Perfusion Systems2002—
+1K111972Affinity CP Centrifugal Pump, Resting Heart Sys.,Myotherm Cardioplegia…Medtronic, Inc.2011—
+1K100645Affinity Pixie Oxygenation System with Carmeda Bioactive Surface or Balance…Medtronic, Inc.2012—
+2K120988DLP Single Stage Venous Cannula, DLP Right Angle Single Stage Venous Cannula…Medtronic, Inc.20122
+3K140165MC2 Two-Stage Venous Cannula, Oval MC2 Two-Stage Venous Cannula, Thin Wall…Medtronic, Inc.2014—
+4K251258MC2™ Two-Stage Venous Cannula; MC2X™ Three-Stage Venous CannulaMedtronic, Inc.2025—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201110
201230
201420
201610
201710
202510
202620
FIG. 1 — Lineage of K021287, 1994–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

Notable FDA decisions, review times and new Class I recalls. See an issue.

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 DTN? 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 DTN device

  1. #1 K251783 Inspire HCR and HCR DUAL cardiotomy reservoirsscore 12.4 · 7 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #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.

TypeNumberDeviceApplicantDecidedRecalls
*K936003Affinity CVR
Summary page 2
…t the blood contact surfaces with Trillium . The Trillium™ AFFINITY NT CVR is being compared to the following marketed devices: e AFFINITY Cardiotomy Venous Reservoir (K936003) e AFFINITY® Hollow Fiber Oxygenator with Trillium™ Biopassive Surface (K973760) The Trillium™ AFFINITY NT CVR has the same indi…
Avecor Cardiovascular, Inc.19943
†K973760Affinity Hollow Fiber Oxygenator with Trillium Biopassive SurfaceAvecor Cardiovascular, Inc.19982

Also cleared against K936003: 2 other devices →

What descends from it? (11)

See all 11

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

NumberDeviceApplicantDecidedDescendants
K111972Affinity CP Centrifugal Pump, Resting Heart Sys.,Myotherm Cardioplegia Deliv.,Affinity…Medtronic, Inc.20115
K100645Affinity Pixie Oxygenation System with Carmeda Bioactive Surface or Balance BiosurfaceMedtronic, Inc.20124

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

Recalls of this device

DateClassRecallRoot causeReason
Jan 16, 2018Class IIZ-0646-2018Process controlPossible sterile barrier breach in the pouch of Affinity NT Cardiotomy Venous Reservoir stand alone uncoated and Affinity NT Cardiotomy Venous Reservoir stand alone Trillium coated products.

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 K936003.

How does its category compare?

All DTN devices

DTN Reservoir, Blood, Cardiopulmonary Bypass: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · DTN

1in 2025

2007: 22008: 12009: 72010: 12011: 22013: 42014: 32015: 22017: 22023: 12024: 22025: 1
2007high 7 (2009) · low 0 (2012)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · DTN

38in 2014

2009: 211 days median2013: 79 days median2014: 38 days median
2007high 211 (2009) · low 38 (2014)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · DTN

2in 2018

2007: 12008: 12009: 12011: 12016: 12017: 12018: 2
2007high 2 (2018) · low 0 (2010)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · DTN

8in 2025

2007: 102008: 82009: 102010: 182011: 102012: 172013: 472014: 522015: 272016: 62017: 32018: 42019: 112020: 62021: 122022: 72023: 82024: 102025: 8
2007high 52 (2014) · low 3 (2017)2025

MAUDE reports naming product code DTN, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20072—110
20081—18
20097211110
20101—018
20112—110
20120—017
2013479047
2014338052
20152—027
20160—16
20172—13
20180—24
20190—011
20200—06
20210—012
20220—07
20231—08
20242—010
20251—08
20260—0—

What is it indicated for?

The Trillium™ AFFINITY NT CVR with Trillium BioPassive Surface is indicated for use in the extracorporeal perfusion circuit to collect venous and Cardiotomy suctioned blood during cardiopulmonary bypass procedures.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

Also cleared against K936003

2 other devices cite the same predicate.

  • K111972Affinity CP Centrifugal Pump, Resting Heart Sys.,Myotherm Cardioplegia Deliv.,Affinity Hollow Fiber…Medtronic, Inc. · 2011
  • K961836Maxima Forte Hardshell Venous ReservoirMedtronic Vascular · 1996

More from Medtronic Perfusion Systems

29 FDA decisions under this applicant name. See the company

  • K240666Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface (BB811); Affinity Fusion…Medtronic Perfusion Systems · 2024
  • K181954autoLog IQ Autotransfusion SystemMedtronic Perfusion Systems · 2018
  • K123351Affinity AF100 Arterial Filter with Carmeda Bioactive SurfaceMedtronic Perfusion Systems · 2013
  • K101186Affinity Vard Sub-Assembly for CPS (Carmeda Coated), Purgeline (Uncoated), Holding BagMedtronic Perfusion Systems · 2010
  • K090869Mircsp (Minimally Invasive Retrograde Coronary Sinus Perfusion) Manual Inflate Cannula, Model 94113TDMedtronic Perfusion Systems · 2009

Recent decisions in DTN

The DTN category page

  • K251783Inspire HCR and HCR DUAL cardiotomy reservoirsSorin Group Italia S.R.L. · 2025
  • K241206Quantum Perfusion Hybrid SystemSpectrum Medical S.R.L. · 2024
  • K241053MVR™ Venous Reservoir Bag 800 mL; MVR™ Venous Reservoir Bag 1600 mL; MVR™ Venous Reservoir Bag with Cortiva™…Medtronic Cardiac Surgery · 2024
  • K223361BMR 1900 PhisioSorin Group Italia S.R.L. · 2023
  • K170583Intersept Filtered Cardiotomy Reservoir with Cortiva BioActive SurfaceMedtronic, Inc. · 2017

https://510kreport.com/device/K021287 · printed Nov 6, 2026

Cite this page

510(k) Report. “K021287: Trillium Affinity NT Cardiotomy Venous Reservoir, Models 540T, 541TT.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K021287

Report an extraction error

Tell us what is wrong; we check it against the FDA summary.

Are you the manufacturer?

Send a correction or an update to this page, for example a newer model or a public statement about a recall.

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