510(k) · Cleared

Cleared

Trillium Bio Disposable Blood Flow Probe (Models DP38T & FP38P)

K012747510(k) SpecialCleared Sep 14, 200129-day reviewClass II21 CFR 870.2120

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

Medtronic Perfusion Systems · DPT Probe, Blood-Flow, Extravascular

Cleared on Sep 14, 2001 as substantially equivalent to K830858 (Bio Medicus, Inc., 1983) after a 29-day review. Its family tree reaches back 1 generation to 1983. 6 later devices descend from it.

Decided: Sep 14, 2001
Review: 29 days
Class: Class II
Product code: DPT
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K830858 (1983). 6 later devices descend from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backK830858 Bio-Probe System-Blood Flow ProbeBio Medicus, Inc. · 1983
This deviceK012747 Trillium Bio Disposable Blood Flow Probe (Models DP38T & FP38P)Medtronic Perfusion Systems · 2001
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 6 descendants. See all descendants

Descendants cleared per year

2011high 2 (2026) · low 0 (2013)2026

Most influential descendants

Showing 5 of 6 · 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	K830858	Bio-Probe System-Blood Flow Probe	Bio Medicus, Inc.	1983	—
0 (this device)	K012747	Trillium Bio Disposable Blood Flow Probe (Models DP38T & FP38P)	Medtronic Perfusion Systems	2001	—
+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
2011	1	0
2012	1	0
2014	1	0
2025	1	0
2026	2	0

FIG. 1 — Lineage of K012747, 1983–2026Source: 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 DPT? 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 DPT device

#1 K233076 Laser Speckle Imaging System (RFLSI CZW)score 8.6 · 5 generations · no Class I recall

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
*	K830858	Bio-Probe System-Blood Flow Probe Summary page 2 …faces with Trillium . The Trillium™ Bio-Probe Disposable Blood Flow Probe is being compared to the following Marketed Devices: e Bio-Probe Disposable Blood Flow Probe (K830858) AFFINITY® Hollow Fiber Oxygenator with Trillium™ Biopassive Surface (K973760) The Trillium™ Bio-Probe Disposable Blood Flow Pr…	Bio Medicus, Inc.	1983	—
†	K973760	Affinity Hollow Fiber Oxygenator with Trillium Biopassive Surface	Avecor Cardiovascular, Inc.	1998	2

Also cleared against K830858: 1 other device →

What descends from it? (6)

1 later device cites 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

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 no recall.
Of its descendants, K111972 (Medtronic, Inc., 2011) has gone furthest, with 5 descendants of its own.
1 other device also cites its predicate K830858.

How does its category compare?

All DPT devices

DPT Probe, Blood-Flow, Extravascular: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · DPT

1in 2024

2007high 3 (2007) · low 0 (2008)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · DPT

201in 2014

2007high 201 (2014) · low 55 (2007)2026

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

Recalls per year · DPT

22in 2024

2007high 22 (2024) · low 0 (2007)2026

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

Adverse event reports per year · DPT

52in 2025

2007high 169 (2024) · low 0 (2013)2025

MAUDE reports naming product code DPT, 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	3	55	0	5
2008	0	—	0	1
2009	1	—	0	3
2010	0	—	0	3
2011	0	—	0	3
2012	2	—	0	1
2013	3	108	0	0
2014	3	201	0	5
2015	1	—	0	0
2016	1	—	0	0
2017	1	—	0	0
2018	0	—	0	3
2019	0	—	0	1
2020	0	—	0	3
2021	0	—	0	13
2022	0	—	0	46
2023	0	—	0	21
2024	1	—	22	169
2025	0	—	0	52
2026	0	—	0	—

What is it indicated for?

The Bio-Probe blood flow monitoring system is to be used with an appropriate model Bio-Console® extracorporeal blood pumping console to measure directly the blood flow in the extracorporeal perfusion circuit.

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/K012747 · printed Nov 4, 2026

Cite this page

510(k) Report. “K012747: Trillium Bio Disposable Blood Flow Probe (Models DP38T & FP38P).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K012747

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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