Atlas FDA

Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

Idev Technologies, Inc. — Predicate Candidate Screening

11 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.

166 daysmedian FDA review time
291 days90th percentile
11clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K130591SUPERA VERITASIdev Technologies, Inc.2013-05-02560
K122546SUPERA VERITAS INTERWOVEN SELF-EXPANDING NITINOL STENT TRANSIdev Technologies, Inc.2012-12-071080
K111627SUPERA VERITAS(R) INTERWOVEN SELF-EXPANDING NITINOL STENT TRIdev Technologies, Inc.2012-08-214380
K111766SUPERA VERITAS INTERWOVEN SELF-EXPANDING NITINOL STENT TRANSIdev Technologies, Inc.2011-10-191181
K093893SUPERA VERITAS INTERWOVEN SELF-EXPANDING NITINOL STENT TRANSIdev Technologies, Inc.2010-10-052911
K071646SUPERA INTERWOVEN SELF-EXPANDING BILIARY NITINOL STENT DELIVIdev Technologies, Inc.2008-01-312270
K060557SURESAVE TM SELF-EXPANDABLE NITINOL STENT AND PRECISION TM DIdev Technologies, Inc.2006-08-151660
K050926TEXAN LONGHORN FOREIGN BODY RETRIEVAL DEVICE, MODEL TX301200Idev Technologies, Inc.2005-05-09260
K041374AKONYA ELIMINATOR MECHANICAL THROMBECTOMY DEVICE, MODEL EL10Idev Technologies, Inc.2005-03-022820
K033188TEXAN FOREIGN BODY RETRIEVAL DEVICE, MODEL TX30060050Idev Technologies, Inc.2003-11-19490
K030504AKONYA ELIMINATOR MECHANICAL THROMBECTOMY DEVICE, MODEL EL 1Idev Technologies, Inc.2003-09-162090

Methodology

Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.

Prepared with Atlas

Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda