510(k) Report

FDA applicant

Idev Technologies, Inc.

Houston, TX11 decisions2003–20132 recalls

FDA records 11 decisions for Idev Technologies, Inc. (Houston, TX) from 2003 to 2013: 11 510(k) clearances. Most are in product codes FGE (Stents, Drains And Dilators For The Biliary…) and MMX (Device, Percutaneous Retrieval). Its devices cite 21 predicates, 9 of them its own earlier devices. 2 recalls are linked to its devices.

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

FIG. A — Illustration, gastroenterology and urology panel, where it files most

How often FDA has decided Idev Technologies, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2013

2008: 12010: 12011: 12012: 22013: 1
2007high 2 (2012) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

2in 2012

2012: 2
2007high 2 (2012) · low 0 (2007)2026

Class I Class II/III not classified

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

Planning a device like Idev Technologies, 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?

  • FGEStents, Drains And Dilators For The Biliary Ducts7decisions
  • MMXDevice, Percutaneous Retrieval2decisions
  • QEWPeripheral Mechanical Thrombectomy With Aspiration1decision
  • MCWCatheter, Peripheral, Atherectomy1decision

Whose devices does it build on?

Its devices cite 21 predicates; 9 are its own earlier devices. The firms it cites most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K093893Supera Veritas Interwoven Self-Expanding Nitinol Stent Transhepatic Biliary SystemIdev Technologies, Inc. · 20103cite it
  • K060557Suresave TM Self-Expandable Nitinol Stent and Precision TM Delivery Catheter-SS06120060Idev Technologies, Inc. · 20062cite it
  • K071646Supera Interwoven Self-Expanding Biliary Nitinol Stent Delivery Catheter, Model # S-04-040-120Idev Technologies, Inc. · 20081cites it
  • K122546Supera Veritas Interwoven Self-Expanding Nitinol Stent Transhepatic Biliary SystemIdev Technologies, Inc. · 20121cites it
  • K030504Akonya Eliminator Mechanical Thrombectomy Device, Model EL 10060060Idev Technologies, Inc. · 20031cites it
  • K111766Supera Veritas Interwoven Self-Expanding Nitinol Stent Transheptic Biliary SystemsIdev Technologies, Inc. · 20111cites it

What has FDA decided for it lately?

  • K130591Supera VeritasIdev Technologies, Inc. · 2013
  • K122546Supera Veritas Interwoven Self-Expanding Nitinol Stent Transhepatic Biliary SystemIdev Technologies, Inc. · 2012
  • K111627Supera Veritas (R) Interwoven Self-Expanding Nitinol Stent Transhepatic Biliary SystemIdev Technologies, Inc. · 2012
  • K111766Supera Veritas Interwoven Self-Expanding Nitinol Stent Transheptic Biliary SystemsIdev Technologies, Inc. · 20111 recall
  • K093893Supera Veritas Interwoven Self-Expanding Nitinol Stent Transhepatic Biliary SystemIdev Technologies, Inc. · 20101 recall
  • K071646Supera Interwoven Self-Expanding Biliary Nitinol Stent Delivery Catheter, Model # S-04-040-120Idev Technologies, Inc. · 2008
  • K060557Suresave TM Self-Expandable Nitinol Stent and Precision TM Delivery Catheter-SS06120060Idev Technologies, Inc. · 2006
  • K050926Texan Longhorn Foreign Body Retrieval Device, Model TX30120060Idev Technologies, Inc. · 2005

All 11 as Idev Technologies, Inc. →

What has been recalled?

2 recalls linked to its devices; the latest:

  • K111766IDEV Technologies SUPERA VERITAS Interwoven Self-Expanding Nitinol Stent Transhepatic…May 29, 2012Class II
  • K093893SUPERA VERITAS Interwoven Self-Expanding Nitinol Stent Transhepatic Biliary System.…Jan 31, 2012