Atlas FDA

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

IRN — Predicate Candidate Screening

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

112 daysmedian FDA review time
254 days90th percentile
11clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K060150SMARTSTEP SYSTEM/SMARSTEP CLINIC SYSTEMAndante Medical Devices , Ltd.2006-02-23340
K023161SMARTSTEP SYSTEMAndante Medical Device, Ltd.2002-12-10780
K991313ACCUTRED SHOEOrthopedic Technology Research, Inc.1999-06-23680
K962591FOOT WEIGHT ALARMCleveland Medical Devices, Inc.1996-12-041550
K960307INDEX SHOEOrthopedic Technology Research, Inc.1996-06-271570
K955034FORCEGUARDImpact Monitors, Inc.1996-04-101600
K950656PED ALERTOrbitec Technologies Corp.1995-10-252540
K931517SAFE-STEPLenjoy Engineering, Inc.1995-03-107140
K882974FORCE GUARD IBoulder Impact Monitors, Inc.1988-11-041120
K792241PELIMITColmed, Ltd.1979-11-30230
K770405OVERLOAD WARNING DEVICESynthes (Usa)1977-03-1070

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