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

Restorative Therapies, Inc. · Predicate Candidate Screening

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

139 daysmedian FDA review time
308 days90th percentile
10clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K162470RT300 FES cycle ergometerRestorative Therapies, Inc.2017-07-113080
K160614Xcite Clinical StationRestorative Therapies, Inc.2016-12-162880
K103370RT200Restorative Therapies, Inc.2011-04-051390
K103366RT600Restorative Therapies, Inc.2011-04-041390
K090750RT300-SL, MODEL FA100052; RT300-SLSA, MODEL FA104581Restorative Therapies, Inc.2009-08-051380
K072398RT300-S AND RT300-SP FES CYCLE ERGOMETERRestorative Therapies, Inc.2007-11-21860
K071486RT300-S, RT300-SP (PEDIATRIC VERSION), MODEL FA100052, FA100Restorative Therapies, Inc.2007-09-101030
K071113RT300-S, MODEL FA100052, RT300-SP (PEDIATRIC VERSION), MODELRestorative Therapies, Inc.2007-07-05760
K060032RT300-S, MODEL FA100052; RT300-SP, MODEL FA100053Restorative Therapies, Inc.2006-03-10640
K050036FES CYCLE ERGOMETER, MODEL RT300-SRestorative Therapies, Inc.2005-06-271710

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