510(k) Report

FDA applicant

Edwards Lifesciences Research Medical

Midvale, UT6 decisions1998–20084 recalls

FDA records 6 decisions for Edwards Lifesciences Research Medical (Midvale, UT) from 1998 to 2008: 6 510(k) clearances. Most are in product codes DWF (Catheter, Cannula And Tubing, Vascular…) and DQR (Cannula, Catheter). Its devices cite 6 predicates, 0 of them its own earlier devices. 4 recalls are linked to its devices, 2 Class I.

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

FIG. A — Illustration, cardiovascular panel, where it files most

How often FDA has decided Edwards Lifesciences Research Medical’s devices, and how often a recall has named them.

FDA decisions per year

1in 2008

2008: 1
2007high 1 (2008) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

2in 2025

2013: 12018: 12025: 2, 2 Class I
2007high 2 (2025) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Edwards Lifesciences Research Medical by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Edwards Lifesciences Research Medical’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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Which product codes does it file in?

  • DWFCatheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass4decisions
  • DQRCannula, Catheter1decision
  • DTMFilter, Blood, Cardiopulmonary Bypass, Arterial Line1decision

Whose devices does it build on?

Its devices cite 6 predicates; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 6 times; 0 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K974259Venous Flex II Peripheral and Intra-Operative Access Venous Return CannulaeEdwards Lifesciences Research Medical · 19982cite it
  • K991170Retrograde Cardioplegia Cannula with Duraflo Treatment, Model Dii-RC-014Edwards Lifesciences Research Medical · 19991cites it
  • K990396T-AnastafloEdwards Lifesciences Research Medical · 19991cites it
  • K07355918 FR. Rmi Arterial Perfusion Cannula II, 20 FR. Rmi Arterial Perfusion Cannula IIEdwards Lifesciences Research Medical · 20081cites it
  • K062429Modification to Embol-X Intra-Aortic Filter: X-Small, Small, Medium, Large, X-Large with Heparin Coated MeshEdwards Lifesciences Research Medical · 20061cites it

What has FDA decided for it lately?

  • K07355918 FR. Rmi Arterial Perfusion Cannula II, 20 FR. Rmi Arterial Perfusion Cannula IIEdwards Lifesciences Research Medical · 20082 Class I recalls
  • K062429Modification to Embol-X Intra-Aortic Filter: X-Small, Small, Medium, Large, X-Large with Heparin Coated MeshEdwards Lifesciences Research Medical · 2006
  • K990396T-AnastafloEdwards Lifesciences Research Medical · 19991 recall
  • K991170Retrograde Cardioplegia Cannula with Duraflo Treatment, Model Dii-RC-014Edwards Lifesciences Research Medical · 1999
  • K983791Peripheral Retrograde Cardiaplegia CannulaEdwards Lifesciences Research Medical · 1999
  • K974259Venous Flex II Peripheral and Intra-Operative Access Venous Return CannulaeEdwards Lifesciences Research Medical · 1998

All 6 as Edwards Lifesciences Research Medical →

What has been recalled?

4 recalls linked to its devices; the latest:

  • K073559Brand Name: Optisite Arterial Cannula Product Name: Optisite Arterial Cannula…May 14, 2025Class I
  • K073559Brand Name: Optisite Arterial Cannula Product Name: Optisite Arterial Cannula…May 14, 2025Class I
  • K073559Edwards Lifesciences Optisite Arterial Perfusion Cannula, 22F X 24CM, resterilized.Mar 7, 2018Class II
  • K990396Edwards Lifesciences Anastaflo Intravascular Shunt, Model code IVS12512, IVS1512…Jul 30, 2013Class II

Other applicant names beginning “Edwards”

FDA records each applicant name separately; these may or may not be the same firm.

Edwards Lifesciences, LLC 177Edwards Pacemaker Systems 13Edwards Laboratories 12Edwards Lifesciences Services GmbH 3Edwards Lifeciences, LLC 3Edwards Lifesiences, LLC 2Edwards Orthopaedics Div., Baxter Healthcare Corp. 2Edwards Lifesciencess, LLC 1Edwards Lfesciences 1Edwards Lifescience, LLC 1Edwards Ventilator Co. 1