Atlas FDA

Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account

OPP · Predicate Candidate Screening

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

112 daysmedian FDA review time
279 days90th percentile
7clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K252757CeQur Simplicity™ On-Demand Insulin Delivery SystemCequr SA2026-04-102240
K243273CeQur Simplicity™ On-Demand Insulin Delivery SystemCequr SA2024-11-13280
K233447CeQur Simplicity™ On-Demand Insulin Delivery SystemCequr SA2024-01-18910
K163357OneTouch Via On-Demand Insulin Delivery SystemLifescan Europe, A Division of Cilag GmbH2017-06-071890
K111924FINESSE PERSONAL INSULIN DELIVERY PATCHCalibra Medical, Inc.2012-04-102790
K100947FINESSE PERSONAL INSULIN DELIVERY PATCH, MODEL FG 2000Calibra Medical, Inc.2010-06-28830
K093065FINESSE PERSONAL INSULIN DELIVERY PATCH, MODEL FG-2000Calibra Medical, Inc.2010-01-201120

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