Atlas FDA

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

ORY — Predicate Candidate Screening

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

114 daysmedian FDA review time
205 days90th percentile
10clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K213159Encore SystemSiesta Medical, Inc.2021-12-22850
K201238Encore SystemSiesta Medical, Inc.2020-10-021480
K183310Encore SystemSiesta Medical, Inc.2019-05-091610
K133680ENCORE SYSTEMSiesta Medical, Inc.2014-03-261140
K121440ENCORE TONGUE SUSPENSION SYSTEM ENCORE REMOVAL-TITRATION KITSiesta Medical, Inc.2012-12-062050
K121814ENCORE TONGUE SUSPENSION SYSTEMSiesta Medical, Inc.2012-11-071400
K111179ENCORE TONGUE SUSPENSION SYSTEM (MONOFILAMENT #1 SUSPENSION Siesta Medical, Inc.2011-07-01650
K110127PRELUDE III TONGUE SUSPENSION SYSTEMSiesta Medical, Inc.2011-04-08800
K103179PRELUDE II TOUNGE SUSPENSION SYSTEMSiesta Medical, Inc.2010-12-20530
K101060SIESTA MEDICAL, INC., PRELUDE TONGUE SUSPENSION SYSTEMSiesta Medical, Inc.2010-07-08840

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