510(k) Report

510(k) · Cleared

Cleared

Trillium Tri-Optic Measurement Cell, Model TMC 25T, TMC38 T, TMC 50T

K012743510(k) SpecialCleared Sep 14, 200129-day reviewClass II21 CFR 870.4330

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

Medtronic Perfusion Systems · DRY Monitor, Blood-Gas, On-Line, Cardiopulmonary Bypass

Cleared on Sep 14, 2001 as substantially equivalent to K910421 (Medtronic Vascular, 1991) and 1 other predicate after a 29-day review. Its family tree reaches back 1 generation to 1991. 7 later devices descend from it.

Decided
Sep 14, 2001
Review
29 days
Class
Class II
Product code
DRY
Recalls
None
Predicates
2

Its longest line of descent runs back 1 generation to K910421 (1991). 2 ancestors in all. 7 later devices descend from it, 2 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 1998: 1 other ancestor2011: 1 descendant cleared2014: 2 descendants cleared2012: 1 descendant cleared2026: 2 descendants cleared2025: 1 descendant clearedK910421 · Saturation/Hematocrit Monitor System · Medtronic Vascular · 19911990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 1 other ancestor 1 generation forward: 2 descendants2 generations forward: 1 descendant3 generations forward: 2 descendants4 generations forward: 1 descendant5 generations forward: 1 descendant K910421 · Saturation/Hematocrit Monitor System · Medtronic Vascular · 19910+5
  1. Root · 1 generation backK910421 Saturation/Hematocrit Monitor SystemMedtronic Vascular · 1991
  2. This deviceK012743 Trillium Tri-Optic Measurement Cell, Model TMC 25T, TMC38 T, TMC 50TMedtronic Perfusion Systems · 2001
  3. Descendant · cites it directly · 5 of its ownK111972 Affinity CP Centrifugal Pump, Resting Heart Sys.,Myotherm…Medtronic, Inc. · 2011
  4. Descendant · 2 generations on · 4 of its ownK120988 DLP Single Stage Venous Cannula, DLP Right Angle Single Stage Venous…Medtronic, Inc. · 2012 · Recalled
  5. Descendant · 3 generations on · 2 of its ownK140165 MC2 Two-Stage Venous Cannula, Oval MC2 Two-Stage Venous Cannula…Medtronic, Inc. · 2014
  6. Descendant · 4 generations on · 1 of its ownK251258 MC2™ Two-Stage Venous Cannula; MC2X™ Three-Stage Venous CannulaMedtronic, Inc. · 2025
  7. Descendant · 5 generations on · 0 of its ownK262052 Tri Stage Venous CannulaeSorin Group Italia S.R.L. · 2026

Showing 5 of 7 descendants. See all descendants

Descendants cleared per year

2011: 12012: 12014: 22025: 12026: 2
2011high 2 (2014) · low 0 (2013)2026

Most influential descendants

Showing 5 of 7 · 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

GenerationNumberDeviceApplicantDecidedRecalls
−1K910421Saturation/Hematocrit Monitor SystemMedtronic Vascular1991—
0 (this device)K012743Trillium Tri-Optic Measurement Cell, Model TMC 25T, TMC38 T, TMC 50TMedtronic Perfusion Systems2001—
+1K111972Affinity CP Centrifugal Pump, Resting Heart Sys.,Myotherm Cardioplegia…Medtronic, Inc.2011—
+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—
+5K262052Tri Stage Venous CannulaeSorin Group Italia S.R.L.2026—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199810

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201110
201210
201420
202510
202620
FIG. 1 — Lineage of K012743, 1991–2026Source: 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 DRY? 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 DRY device

  1. #1 K234065 CDI OneView Monitoring Systemscore 5.5 · 2 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? (2)

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
*K910421Saturation/Hematocrit Monitor System
Summary page 1
…duct Regulations Manager, Regulatory Affairs DEVICE NAME Trillium™ Tri-oEtic Measurement Cell NAME OF PREDICATED OR LEGALLY MARKETED DEVICE Tri-optic Measurement Cell K910421) § /—T) AFFINITY® Hollow Fiber Oxygena h Trillium™ Biopassive Surfe@(973760) P - ~ DESCRIPTION OF DEVICE / The Trillium™ Tri-op…
Medtronic Vascular1991—
*K973760Affinity Hollow Fiber Oxygenator with Trillium Biopassive Surface
Summary page 2
…Cell is being compared to the following marketed devices: e Tri-optic Measurement Cell (K910421) e AFFINITY® Hollow Fiber Oxygenator with Trillium™ Biopassive Surface (K973760) The Trillium™ Tri-optic Measurement Cell has the same indications statement and intended uses as the: e Tri-optic Measurement…
Avecor Cardiovascular, Inc.19982

Also cleared against K910421: 2 other devices →

What descends from it? (7)

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
K133157Tri-Optic Measurement Cell; with Balance Biosurface, with Carmeda Bioactive Surface…Medtronic, Inc.20140

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?

  • 1 of the 2 ancestors has a recall of any class.
  • Of its descendants, K111972 (Medtronic, Inc., 2011) has gone furthest, with 5 descendants of its own.
  • 2 other devices also cite its predicate K910421.

How does its category compare?

All DRY devices

DRY Monitor, Blood-Gas, On-Line, Cardiopulmonary Bypass: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · DRY

1in 2024

2007: 22009: 22011: 22012: 12014: 22017: 12018: 32020: 12021: 12024: 1
2007high 3 (2018) · low 0 (2008)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · DRY

88in 2018

2018: 88 days median
2007high 88 (2018)2026

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

Recalls per year · DRY

1in 2020

2008: 12010: 62011: 142012: 52015: 12020: 1
2007high 14 (2011) · low 0 (2007)2026

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

Adverse event reports per year · DRY

134in 2025

2008: 12009: 22010: 1,0702011: 2,2682012: 1672013: 1572014: 1562015: 2312016: 2402017: 612018: 1652019: 632020: 352021: 422022: 372023: 412024: 722025: 134
2007high 2,268 (2011) · low 0 (2007)2025

MAUDE reports naming product code DRY, 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—00
20080—11
20092—02
20100—61,070
20112—142,268
20121—5167
20130—0157
20142—0156
20150—1231
20160—0240
20171—061
20183880165
20190—063
20201—135
20211—042
20220—037
20230—041
20241—072
20250—0134
20260—0—

What is it indicated for?

The Trillium™ Tri-optic Measurement Cell is intended for use in the BioTrend oxygen saturation and hematocrit system.

The BioTrend oxygen saturation and hematocrit system measures percent oxygen saturation and hematocrit of the blood in the extracorporeal circuit. The extracorporeal circuit is used for, but is not limited to, cardiopulmonary bypass, closed chest support and limb perfusion.

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 K910421

2 other devices cite the same predicate.

  • K133157Tri-Optic Measurement Cell; with Balance Biosurface, with Carmeda Bioactive Surface, with Trillium…Medtronic, Inc. · 2014
  • K111972Affinity CP Centrifugal Pump, Resting Heart Sys.,Myotherm Cardioplegia Deliv.,Affinity Hollow Fiber…Medtronic, Inc. · 2011

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 DRY

The DRY category page

  • K234065CDI OneView Monitoring SystemTerumo Cardiovascular Systems Corporation · 20242 recalls
  • K202154B-CaptaLivanova Deutschland, GmbH · 2021
  • K202557Quantum Workstation 12 EliteSpectrum Medical, Ltd. · 2020
  • K182110CDI Blood Parameter Monitoring System 550Terumo Cardiovascular Systems Corporation · 2018
  • K181923Quantum Workstation 12.1Spectrum Medical, Ltd. · 2018

https://510kreport.com/device/K012743 · printed Nov 4, 2026

Cite this page

510(k) Report. “K012743: Trillium Tri-Optic Measurement Cell, Model TMC 25T, TMC38 T, TMC 50T.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K012743

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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