510(k) Report

FDA applicant

Estech, Inc.

Alameda, CA7 decisions1999–20131 recall

FDA records 7 decisions for Estech, Inc. (Alameda, CA) from 1999 to 2013: 7 510(k) clearances. Most are in product codes GEI (Electrosurgical, Cutting & Coagulation &…) and DWF (Catheter, Cannula And Tubing, Vascular…). Its devices cite 10 predicates, 2 of them its own earlier devices. 1 recall is linked to its devices.

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 Estech, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2013

2013: 1
2007high 1 (2013) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

1in 2017

2017: 1
2007high 1 (2017) · low 0 (2007)2026

Class I Class II/III not classified

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

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

See the 510(k) Report

Which product codes does it file in?

  • GEIElectrosurgical, Cutting & Coagulation & Accessories3decisions
  • DWFCatheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass2decisions
  • DXCClamp, Vascular1decision
  • DTSSucker, Cardiotomy Return, Cardiopulmonary Bypass1decision

Whose devices does it build on?

Its devices cite 10 predicates; 2 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 13 times; 2 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.

  • K051749Cobra Surgical SystemEstech, Inc. · 20055cite it
  • K990573Estech Arterial Remote Access Perfusion CannulaEstech, Inc. · 19993cite it
  • K052081Remote Access Perfusion (Rap) Femoral Venous CannulaEstech, Inc. · 20052cite it
  • K041599Cobra Adhere Surgical SystemEstech, Inc. · 20042cite it
  • K032632Remote Access Perfusion Cannula Left Axillary 21 FrenchEstech, Inc. · 20031cites it

What has FDA decided for it lately?

  • K133017Estech Cobra (R) Genesis Bipolar ClampEstech, Inc. · 2013
  • K053021Estech Clearview MV Atrial DepressorEstech, Inc. · 2006
  • K052081Remote Access Perfusion (Rap) Femoral Venous CannulaEstech, Inc. · 20051 recall
  • K051749Cobra Surgical SystemEstech, Inc. · 2005
  • K041599Cobra Adhere Surgical SystemEstech, Inc. · 2004
  • K032632Remote Access Perfusion Cannula Left Axillary 21 FrenchEstech, Inc. · 2003
  • K990573Estech Arterial Remote Access Perfusion CannulaEstech, Inc. · 1999

All 7 as Estech, Inc. →

What has been recalled?

1 recall linked to its devices; the latest:

  • K052081FlexFlow Venous Cannula Model/Catalog Number 200-200 The FlexFlow Venous Cannula is a…Sep 28, 2017Class II