510(k) · Cleared

Cleared

Modofication to Afffinity 38 Micro Arterial Blood Filter with Carmeda Bioactive Surface, Models CB351/CB352

K000379510(k) SpecialCleared Feb 16, 20009-day reviewClass II21 CFR 870.4260

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

Medtronic Vascular · DTM Filter, Blood, Cardiopulmonary Bypass, Arterial Line

Cleared on Feb 16, 2000 after a 9-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 8 later devices descend from it.

Decided: Feb 16, 2000
Review: 9 days
Class: Class II
Product code: DTM
Recalls: None
Predicates: 0

8 later devices descend from it, 2 citing it directly.

This deviceK000379 Modofication to Afffinity 38 Micro Arterial Blood Filter with…Medtronic Vascular · 2000
Descendant · cites it directly · 7 of its ownK071253 Affinity Pediatric Arterial Filter, Model S4014 and with Carmeda…Medtronic Vascular · 2007 · 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 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

Showing 5 of 8 descendants. See all descendants

Descendants cleared per year

2007high 3 (2026) · low 0 (2008)2026

Most influential descendants

Showing 5 of 8 · See all

K071253Affinity Pediatric Arterial Filter, Model S4014 and with Carmeda Bioactive Surface…Medtronic Vascular · 2007 · cites it directly7descendants
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

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K000379	Modofication to Afffinity 38 Micro Arterial Blood Filter with Carmeda…	Medtronic Vascular	2000	—
+1	K071253	Affinity Pediatric Arterial Filter, Model S4014 and with Carmeda Bioactive…	Medtronic Vascular	2007	2
+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	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2007	1	0
2011	1	0
2012	1	0
2014	1	0
2025	1	0
2026	3	0

FIG. 1 — Lineage of K000379, 2000–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in DTM? 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 DTM device

#1 K251744 Affinity Pixie™ Arterial Filter with Balance™…score 11.0 · 2 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?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (8)

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

Number	Device	Applicant	Decided	Descendants
K071253	Affinity Pediatric Arterial Filter, Model S4014 and with Carmeda Bioactive Surface…	Medtronic Vascular	2007	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)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

Of its descendants, K071253 (Medtronic Vascular, 2007) has gone furthest, with 7 descendants of its own.

How does its category compare?

All DTM devices

DTM Filter, Blood, Cardiopulmonary Bypass, Arterial Line: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · DTM

2in 2024

2007high 5 (2009) · low 0 (2014)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · DTM

246in 2009

2007high 246 (2009) · low 60 (2007)2026

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

Recalls per year · DTM

1in 2019

2007high 1 (2008) · low 0 (2007)2026

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

Adverse event reports per year · DTM

4in 2024

2007high 64 (2014) · low 0 (2009)2025

MAUDE reports naming product code DTM, 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	60	0	8
2008	1	—	1	2
2009	5	246	0	0
2010	2	—	0	3
2011	1	—	0	8
2012	2	—	0	6
2013	1	—	0	9
2014	0	—	0	64
2015	0	—	0	34
2016	0	—	0	27
2017	0	—	0	15
2018	0	—	0	23
2019	0	—	1	5
2020	0	—	0	1
2021	0	—	0	1
2022	0	—	0	4
2023	1	—	0	0
2024	2	—	0	4
2025	0	—	0	0
2026	1	—	0	—

https://510kreport.com/device/K000379 · printed Nov 4, 2026

Cite this page

510(k) Report. “K000379: Modofication to Afffinity 38 Micro Arterial Blood Filter with Carmeda Bioactive Surface, Models CB351/CB352.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K000379

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Record history

FDA decision record loaded May 2, 2026
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026