510(k) Report

510(k) · Cleared

Recalled · 2008

Various Cardiovascular Surgical Device

K831769510(k) TraditionalCleared Aug 12, 198372-day reviewClass II21 CFR 870.4210Recalls 8

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

Research Industries Corp. · DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass

Cleared on Aug 12, 1983 after a 72-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 8 later devices descend from it. It has been recalled 8 times.

Decided
Aug 12, 1983
Review
72 days
Class
Class II
Product code
DWF
Recalls
8
Predicates
0

8 later devices descend from it, 4 citing it directly.

Descendants, by year cleared 2013: 1 descendant cleared2012: 2 descendants cleared1998: 1 descendant cleared2024: 1 descendant cleared2009: 1 descendant cleared1999: 1 descendant cleared2025: 1 descendant cleared19801990200020102020
  1. This deviceK831769 Various Cardiovascular Surgical DeviceResearch Industries Corp. · 1983
  2. Descendant · cites it directly · 3 of its ownK974259 Venous Flex II Peripheral and Intra-Operative Access Venous Return…Edwards Lifesciences Research Medical · 1998
  3. Descendant · cites it directly · 1 of its ownK123370 EZ Glide Aortic Cannula, Aortic Perfusion Cannula with Duraflo…Edwards Lifesciences, LLC · 2013 · Recalled
  4. Descendant · 2 generations on · 1 of its ownK091542 Estech Easyflow Cannula with GuidewireEndoscopic Technologies, Inc. D/B/A Estech · 2009
  5. Descendant · 3 generations on · 0 of its ownK250610 Easyflow (103-200; 103-300); Easyflow Duo (103-210; 103-310)Sorin Group Italia S.R.L. · 2025
  6. Descendant · 2 generations on · 0 of its ownK233895 EZ Glide Aortic Perfusion Cannulae (EZC21A, EZC21TA, EZC24A…Edwards Lifesciences · 2024

Showing 5 of 8 descendants. See all descendants

Descendants cleared per year

1998: 11999: 12009: 12012: 22013: 12024: 12025: 1
1998high 2 (2012) · low 0 (2000)2026

Most influential descendants

Showing 5 of 8 · See all
  • K974259Venous Flex II Peripheral and Intra-Operative Access Venous Return CannulaeEdwards Lifesciences Research Medical · 1998 · cites it directly3descendants
  • K123370EZ Glide Aortic Cannula, Aortic Perfusion Cannula with Duraflo Coating, Dispersion…Edwards Lifesciences, LLC · 2013 · cites it directly1descendant
  • K091542Estech Easyflow Cannula with GuidewireEndoscopic Technologies, Inc. D/B/A Estech · 2009 · 2 generations on1descendant
  • K250610Easyflow (103-200; 103-300); Easyflow Duo (103-210; 103-310)Sorin Group Italia S.R.L. · 2025 · 3 generations on0descendants
  • K233895EZ Glide Aortic Perfusion Cannulae (EZC21A, EZC21TA, EZC24A, EZC24TA, EZF21A, EZF21TA…Edwards Lifesciences · 2024 · 2 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K831769Various Cardiovascular Surgical DeviceResearch Industries Corp.1983—
+1K974259Venous Flex II Peripheral and Intra-Operative Access Venous Return CannulaeEdwards Lifesciences Research Medical1998—
+1K123370EZ Glide Aortic Cannula, Aortic Perfusion Cannula with Duraflo Coating…Edwards Lifesciences, LLC20134
+2K091542Estech Easyflow Cannula with GuidewireEndoscopic Technologies, Inc. D/B/A Estech2009—
+3K250610Easyflow (103-200; 103-300); Easyflow Duo (103-210; 103-310)Sorin Group Italia S.R.L.2025—
+2K233895EZ Glide Aortic Perfusion Cannulae (EZC21A, EZC21TA, EZC24A, EZC24TA, EZF21A…Edwards Lifesciences2024—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199810
199910
200910
201220
201310
202410
202510
FIG. 1 — Lineage of K831769, 1983–2025Source: 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.

Planning a device in DWF? 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 DWF device

  1. #1 K251258 MC2™ Two-Stage Venous Cannula; MC2X™…score 14.7 · 8 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? (8)

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

NumberDeviceApplicantDecidedDescendants
K974259Venous Flex II Peripheral and Intra-Operative Access Venous Return CannulaeEdwards Lifesciences Research Medical19983
K123370EZ Glide Aortic Cannula, Aortic Perfusion Cannula with Duraflo Coating, Dispersion…Edwards Lifesciences, LLC20131
K113411Edward Vent Catheters Edward Vent Catheters with Duraflo Coating Dispersion Aortic…Edwards Lifesciences, LLC20120
K120072Venous Drainage Cannula with Duraflo CoatingEdwards Lifesciences, LLC20120

Has anything in its family been recalled? (0 Class I)

Recalls of this device

DateClassRecallRoot causeReason
Jul 14, 2008Not classifiedZ-2401-2008Process controlReinforcement spring may detach from the cannula body resulting in reduced venous blood return flow.
Jul 14, 2008Not classifiedZ-2402-2008Process controlReinforcement spring may detach from the cannula body resulting in reduced venous blood return flow.
Jul 14, 2008Not classifiedZ-2403-2008Process controlReinforcement spring may detach from the cannula body resulting in reduced venous blood return flow.
Apr 18, 2006Not classifiedZ-1092-06OtherDue to potential embrittlement of the plastic tip which may crack or separate during use.
Apr 18, 2006Not classifiedZ-1091-06OtherDue to potential embrittlement of the plastic tip which may crack or separate during use.
Apr 18, 2006Not classifiedZ-1093-06OtherDue to potential embrittlement of the plastic tip which may crack or separate during use.
Apr 18, 2006Not classifiedZ-1090-06OtherDue to potential embrittlement of the plastic tip which may crack or separate during use.
Apr 18, 2006Not classifiedZ-1089-06OtherDue to potential embrittlement of the plastic tip which may crack or separate during use.

The 5 latest of 8 recalls; the web page lists all.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Of its descendants, K974259 (Edwards Lifesciences Research Medical, 1998) has gone furthest, with 3 descendants of its own.

How does its category compare?

All DWF devices

DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · DWF

4in 2025

2007: 22008: 62009: 82010: 32011: 52012: 102013: 92014: 142015: 92016: 32017: 52018: 52019: 32020: 32021: 52022: 22023: 22024: 32025: 42026 (partial year): 8
2007high 14 (2014) · low 2 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · DWF

89in 2025

2008: 95 days median2009: 148 days median2010: 62 days median2011: 85 days median2012: 110 days median2013: 110 days median2014: 110 days median2015: 46 days median2016: 32 days median2017: 127 days median2018: 30 days median2019: 120 days median2020: 30 days median2021: 358 days median2024: 29 days median2025: 89 days median2026 (partial year): 81 days median
2007high 358 (2021) · low 29 (2024)2026

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

Recalls per year · DWF

4in 2024

2007: 252008: 252009: 212010: 262011: 132012: 372013: 14, 1 Class I2014: 62015: 3, 1 Class I2016: 32017: 2, 1 Class I2018: 102019: 22021: 32024: 42026 (partial year): 20
2007high 37 (2012) · low 0 (2020)2026

Class I (3 since 2007) Class II/III not classified

Adverse event reports per year · DWF

1,020in 2025

2007: 1212008: 1262009: 992010: 1972011: 2122012: 2332013: 2382014: 3252015: 2182016: 1442017: 1012018: 1182019: 1792020: 1422021: 1622022: 2762023: 4702024: 4012025: 1,020
2007high 1,020 (2025) · low 99 (2009)2025

MAUDE reports naming product code DWF, 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—25121
200869525126
200981482199
201036226197
201158513212
20121011037233
2013911014 (1)238
2014141106325
20159463 (1)218
20163323144
201751272 (1)101
201853010118
201931202179
20203300142
202153583162
20222—0276
20232—0470
20243294401
202548901,020
202688120—

More from Research Industries Corp.

5 FDA decisions under this applicant name. See the company

  • K945931Rmi Cirkuit-Guard (TM) Pressure Relief ValveResearch Industries Corp. · 1995
  • K833433Physio-Probe-High Permeability Cath.Research Industries Corp. · 1983
  • K832542I.V. Administration SetResearch Industries Corp. · 1983
  • K831759Intracardia SuckersResearch Industries Corp. · 19832 recalls

Recent decisions in DWF

The DWF category page

  • K263092Dual Stage Venous CannulaeSorin Group Italia S.R.L. · 2026
  • K262052Tri Stage Venous CannulaeSorin Group Italia S.R.L. · 2026
  • K260195Elongated One-Piece Arterial (EOPA) 3D™ Arterial CannulaeMedtronic, Inc. · 20262 recalls
  • K250937Venous Return CannulaeLivaNova USA, Inc. · 2026
  • K260043Smart Reactors Camouflage Coated Extracorporeal Cardiopulmonary Tubing Set (SR180C)Smart Reactors · 2026

https://510kreport.com/device/K831769 · printed Nov 3, 2026

Cite this page

510(k) Report. “K831769: Various Cardiovascular Surgical Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K831769

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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