510(k) Report

FDA applicant

Embol-X, Inc.

Mountain View, CA4 decisions1999–20032 recalls

FDA records 4 decisions for Embol-X, Inc. (Mountain View, CA) from 1999 to 2003: 4 510(k) clearances. Most are in product codes DWF (Catheter, Cannula And Tubing, Vascular…) and DYB (Introducer, Catheter). Its devices cite 6 predicates, 0 of them its own earlier devices. 2 recalls are linked to its devices, 1 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 Embol-X, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Embol-X, Inc. since 2007.

Recalls per year

1in 2013

2013: 1, 1 Class I
2007high 1 (2013) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Embol-X, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Embol-X, Inc.’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 Bypass1decision
  • DYBIntroducer, Catheter1decision
  • DTMFilter, Blood, Cardiopulmonary Bypass, Arterial Line1decision
  • DXCClamp, Vascular1decision

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 4 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.

  • K022071Embol-X Aortic Filters,Etra-Small,Small,Medium,Large,Extra Large,Models CF26000.CF29000,CF32000,CF35000,CF4000Embol-X, Inc. · 20032cite it
  • K020693Aortic Cannula, Metal J-Tip (24FR) Model #CF00100; Aortic Cannula, Plastic J-Tip (24FR) Model #CF00101Embol-X, Inc. · 20021cites it
  • K002973Embol-X Introducer, Model CF00200Embol-X, Inc. · 20011cites it

What has FDA decided for it lately?

  • K022071Embol-X Aortic Filters,Etra-Small,Small,Medium,Large,Extra Large,Models CF26000.CF29000,CF32000,CF35000,CF4000Embol-X, Inc. · 20031 Class I recall
  • K020693Aortic Cannula, Metal J-Tip (24FR) Model #CF00100; Aortic Cannula, Plastic J-Tip (24FR) Model #CF00101Embol-X, Inc. · 20021 recall
  • K002973Embol-X Introducer, Model CF00200Embol-X, Inc. · 2001
  • K980631Embol-X Aortic Occlusion and Cardioplegia CannulaEmbol-X, Inc. · 1999

All 4 as Embol-X, Inc. →

What has been recalled?

2 recalls linked to its devices; the latest:

  • K022071Edwards Lifesciences EMBOL-X Glide Protection System; Model Numbers: EXGF24D, EXGF24LLD…Sep 16, 2013Class I
  • K020693EMBOL-X Slim Access Device / Aortic Cannula 24 Fr X 11''.Nov 19, 2004