Idev Technologies, Inc.: FDA filings under this applicant name
FDA lists 11 510(k) clearances under the applicant name “Idev Technologies, Inc.” (first 2003, latest 2013), across 4 product codes in 2 review panels. Median 510(k) review time under this name: 166 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 2 | 273 |
| 2013 | 1 | 56 |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| FGE | Stents, Drains And Dilators For The Biliary Ducts | 7 | 7 |
| MMX | Device, Percutaneous Retrieval | 2 | 2 |
| MCW | Catheter, Peripheral, Atherectomy | 1 | 1 |
| QEW | Peripheral Mechanical Thrombectomy With Aspiration | 1 | 1 |
Review panels
Most recent Idev Technologies, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K130591 | SUPERA VERITAS | FGE | 2013-05-02 | 56 |
| K122546 | SUPERA VERITAS INTERWOVEN SELF-EXPANDING NITINOL STENT TRANSHEPATIC BILIARY SYSTEM | FGE | 2012-12-07 | 108 |
| K111627 | SUPERA VERITAS(R) INTERWOVEN SELF-EXPANDING NITINOL STENT TRANSHEPATIC BILIARY SYSTEM | FGE | 2012-08-21 | 438 |
| K111766 | SUPERA VERITAS INTERWOVEN SELF-EXPANDING NITINOL STENT TRANSHEPTIC BILIARY SYSTEMS | FGE | 2011-10-19 | 118 |
| K093893 | SUPERA VERITAS INTERWOVEN SELF-EXPANDING NITINOL STENT TRANSHEPATIC BILIARY SYSTEM | FGE | 2010-10-05 | 291 |
| K071646 | SUPERA INTERWOVEN SELF-EXPANDING BILIARY NITINOL STENT DELIVERY CATHETER, MODEL # S-04-040-120 | FGE | 2008-01-31 | 227 |
| K060557 | SURESAVE TM SELF-EXPANDABLE NITINOL STENT AND PRECISION TM DELIVERY CATHETER-SS06120060 | FGE | 2006-08-15 | 166 |
| K050926 | TEXAN LONGHORN FOREIGN BODY RETRIEVAL DEVICE, MODEL TX30120060 | MMX | 2005-05-09 | 26 |
| K041374 | AKONYA ELIMINATOR MECHANICAL THROMBECTOMY DEVICE, MODEL EL10060060 | QEW | 2005-03-02 | 282 |
| K033188 | TEXAN FOREIGN BODY RETRIEVAL DEVICE, MODEL TX30060050 | MMX | 2003-11-19 | 49 |
1 earlier clearances. See the full list in Caduvo.
Recalls
2 product recalls in 2 recall events; 0 initiated in the last five years. Most recent: 2012-05-29.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Frequently asked questions
How many FDA 510(k) clearances are listed under Idev Technologies, Inc.?
FDA lists 11 510(k) clearances under the applicant name “Idev Technologies, Inc.” (first 2003, latest 2013), across 4 product codes in 2 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Idev Technologies, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Idev Technologies, Inc. is 166 days.
Which FDA product codes appear under Idev Technologies, Inc.?
The most frequent FDA product codes under this applicant name are FGE (Stents, Drains And Dilators For The Biliary Ducts, 7); MMX (Device, Percutaneous Retrieval, 2); MCW (Catheter, Peripheral, Atherectomy, 1).
Next steps
- See all 11 Idev Technologies, Inc. clearances with predicates and recalls
- Run predicate analysis for product code FGE, Idev Technologies, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.