510(k) Report

510(k) · Cleared

Cleared

Affinity Venous Reservior Bag

K935717510(k) TraditionalCleared May 10, 1994161-day reviewClass II21 CFR 870.4400

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

Avecor Cardiovascular, Inc. · DTN Reservoir, Blood, Cardiopulmonary Bypass

Cleared on May 10, 1994 after a 161-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 2 of the 16 devices in its family, counting itself, have a Class I recall. 15 later devices descend from it.

Decided
May 10, 1994
Review
161 days
Class
Class II
Product code
DTN
Recalls
None
Predicates
0

15 later devices descend from it, 2 citing it directly. 2 of the 16 devices in this family, counting this one, have a Class I recall.

Descendants, by year cleared 1998: 1 descendant cleared2003: 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 cleared1990200020102020
  1. This deviceK935717 Affinity Venous Reservior BagAvecor Cardiovascular, Inc. · 1994
  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 15 descendants. See all descendants

Descendants cleared per year

1998: 12003: 12009: 22010: 12011: 32012: 12013: 12014: 22025: 12026: 2
1998high 3 (2011) · low 0 (1999)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 15 · 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)K935717Affinity Venous Reservior BagAvecor Cardiovascular, Inc.1994—
+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
199810
200310
200920
201010
201131
201210
201310
201421
202510
202620
FIG. 1 — Lineage of K935717, 1994–2026Source: 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.

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?

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

What descends from it? (15)

See all 15

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

NumberDeviceApplicantDecidedDescendants
K031700Medtronic Resting Heart System, Model AAR1000 and 711Medtronic Perfusion Systems200313
K981628Bard Quantum SVR Model Number H-6440VRC.R. Bard, Inc.19980

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 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—

More from Avecor Cardiovascular, Inc.

9 FDA decisions under this applicant name. See the company

  • K973760Affinity Hollow Fiber Oxygenator with Trillium Biopassive SurfaceAvecor Cardiovascular, Inc. · 19982 recalls
  • K964017Affinity Blood Pump SystemAvecor Cardiovascular, Inc. · 1997
  • K971105Myotherm (TM) XP Cardioplegia Delivery SystemAvecor Cardiovascular, Inc. · 1997
  • K952532Affinity Arterial Blood FilterAvecor Cardiovascular, Inc. · 19951 recall
  • K940126Avecor Pre-Bypass FilterAvecor Cardiovascular, Inc. · 1994

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/K935717 · printed Nov 6, 2026

Cite this page

510(k) Report. “K935717: Affinity Venous Reservior Bag.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K935717

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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