510(k) Report

510(k) · Cleared

Cleared

Medtronic Overpressure/Vacuum Relief Valve

K953564510(k) TraditionalCleared Feb 2, 1996186-day reviewClass II21 CFR 870.4290

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

Medtronic Cardiac Surgery, Medtronic, Inc. · DTL Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass

Cleared on Feb 2, 1996 after a 186-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 2 of the 15 devices in its family, counting itself, have a Class I recall. 14 later devices descend from it.

Decided
Feb 2, 1996
Review
186 days
Class
Class II
Product code
DTL
Recalls
None
Predicates
0

14 later devices descend from it, 1 citing it directly. 2 of the 15 devices in this family, counting this one, have a Class I recall.

Descendants, by year cleared 2003: 1 descendant cleared2009: 2 descendants cleared2011: 3 descendants cleared, 1 with a Class I recall12010: 1 descendant cleared2012: 1 descendant cleared2013: 1 descendant cleared2014: 2 descendants cleared, 1 with a Class I recall12026: 2 descendants cleared2025: 1 descendant cleared1995200020052010201520202025
  1. This deviceK953564 Medtronic Overpressure/Vacuum Relief ValveMedtronic Cardiac Surgery, Medtronic, Inc. · 1996
  2. Descendant · cites it directly · 13 of its ownK031700 Medtronic Resting Heart System, Model AAR1000 and 711Medtronic Perfusion Systems · 2003 · Recalled
  3. Descendant · 2 generations on · 5 of its ownK111972 Affinity CP Centrifugal Pump, Resting Heart Sys.,Myotherm…Medtronic, Inc. · 2011
  4. Descendant · 2 generations on · 5 of its ownK090006 Lifebridge B2T, Model 7001Lifebridge Medizintechnik AG · 2009
  5. Descendant · 3 generations on · 4 of its ownK120988 DLP Single Stage Venous Cannula, DLP Right Angle Single Stage Venous…Medtronic, Inc. · 2012 · Recalled
  6. Descendant · 4 generations on · 2 of its ownK140165 MC2 Two-Stage Venous Cannula, Oval MC2 Two-Stage Venous Cannula…Medtronic, Inc. · 2014

Showing 5 of 14 descendants. See all descendants

Descendants cleared per year

2003: 12009: 22010: 12011: 32012: 12013: 12014: 22025: 12026: 2
2003high 3 (2011) · low 0 (2004)2026

Class I recalls in this family

  • K102726 Cardiohelp System3 generations on · 2011
  • K133598 Cardiohelp System4 generations on · 2014

Most influential descendants

Showing 5 of 14 · See all
  • K031700Medtronic Resting Heart System, Model AAR1000 and 711Medtronic Perfusion Systems · 2003 · cites it directly13descendants
  • K111972Affinity CP Centrifugal Pump, Resting Heart Sys.,Myotherm Cardioplegia Deliv.,Affinity…Medtronic, Inc. · 2011 · 2 generations on5descendants
  • K090006Lifebridge B2T, Model 7001Lifebridge Medizintechnik AG · 2009 · 2 generations on5descendants
  • K120988DLP Single Stage Venous Cannula, DLP Right Angle Single Stage Venous Cannula, DLP Single…Medtronic, Inc. · 2012 · 3 generations on4descendants
  • K140165MC2 Two-Stage Venous Cannula, Oval MC2 Two-Stage Venous Cannula, Thin Wall Two-Stage…Medtronic, Inc. · 2014 · 4 generations on2descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K953564Medtronic Overpressure/Vacuum Relief ValveMedtronic Cardiac Surgery, Medtronic, Inc.1996—
+1K031700Medtronic Resting Heart System, Model AAR1000 and 711Medtronic Perfusion Systems20031
+2K111972Affinity CP Centrifugal Pump, Resting Heart Sys.,Myotherm Cardioplegia…Medtronic, Inc.2011—
+2K090006Lifebridge B2T, Model 7001Lifebridge Medizintechnik AG2009—
+3K120988DLP Single Stage Venous Cannula, DLP Right Angle Single Stage Venous Cannula…Medtronic, Inc.20122
+4K140165MC2 Two-Stage Venous Cannula, Oval MC2 Two-Stage Venous Cannula, Thin Wall…Medtronic, Inc.2014—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200310
200920
201010
201131
201210
201310
201421
202510
202620
FIG. 1 — Lineage of K953564, 1996–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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

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.

2 devices in this family have a Class I recall. A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

  • Candidate predicates for a device like this, rankedin the report
  • Recall history across each candidate’s familyin the report
Get a 510(k) Report

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? (14)

See all 14

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K031700Medtronic Resting Heart System, Model AAR1000 and 711Medtronic Perfusion Systems200313

Has anything in its family been recalled? (2 Class I)

No FDA recall names this device.

Relatives with a Class I recall

Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.

  • K102726Cardiohelp SystemMaquet Cardiopulmonary, AG · 2011 · 3 generations on · ◆ in the 2011 descendants bar of FIG. 11 Class I recall
  • K133598Cardiohelp SystemMaquet Cardiopulmonary, AG · 2014 · 4 generations on · ◆ in the 2014 descendants bar of FIG. 11 Class I recall

What does this lineage say?

  • Of its descendants, K031700 (Medtronic Perfusion Systems, 2003) has gone furthest, with 13 descendants of its own.

How does its category compare?

All DTL devices

DTL Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · DTL

1in 2015

2007: 12008: 52009: 22010: 42012: 82013: 12014: 22015: 1
2007high 8 (2012) · low 0 (2011)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · DTL

36in 2012

2008: 85 days median2010: 115 days median2012: 36 days median
2007high 115 (2010) · low 36 (2012)2026

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

Recalls per year · DTL

1in 2025

2008: 12010: 32011: 12012: 22013: 1, 1 Class I2014: 12017: 22022: 22025: 12026 (partial year): 3, 3 Class I
2007high 3 (2010) · low 0 (2007)2026

Class I (4 since 2007) Class II/III not classified

Adverse event reports per year · DTL

110in 2025

2007: 372008: 162009: 622010: 1482011: 1602012: 532013: 672014: 802015: 892016: 672017: 1062018: 842019: 762020: 532021: 552022: 482023: 462024: 4522025: 110
2007high 452 (2024) · low 16 (2008)2025

MAUDE reports naming product code DTL, 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
20071—037
2008585116
20092—062
201041153148
20110—1160
2012836253
20131—1 (1)67
20142—180
20151—089
20160—067
20170—2106
20180—084
20190—076
20200—053
20210—055
20220—248
20230—046
20240—0452
20250—1110
20260—3 (3)—

More from Medtronic Cardiac Surgery, Medtronic…

2 FDA decisions under this applicant name. See the company

  • K960755Cardiotherm Blood Cardioplegia SystemsMedtronic Cardiac Surgery, Medtronic, Inc. · 1996

Recent decisions in DTL

The DTL category page

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  • K143429Passage Hemostasis ValveMerit Medical Systems, Inc. · 2014
  • K140475Rotating AdaptersMerit Medical Systems, Inc. · 2014
  • K131124ColignJilin Coronado Medical, Ltd. · 2013
  • K123448Affinity Flexible Luer Lock Adapter with Balance Biosurface, Affinity Flexible Luer Lock Adapter with…Medtronic, Inc. · 2012

https://510kreport.com/device/K953564 · printed Nov 4, 2026

Cite this page

510(k) Report. “K953564: Medtronic Overpressure/Vacuum Relief Valve.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K953564

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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