K252757

The CeQur Simplicity is a wearable three-day insulin patch that delivers bolus doses on demand — distinct from continuous-infusion insulin pumps. Product code OPP covers insulin delivery systems; CeQur positioned Simplicity as a bridge between multiple daily injections and full pump therapy.

General Hospital panel, Special 510(k) — meaning the filing was a design change to a previously cleared device rather than a new device evaluation. Special 510(k) is FDA's fast-track for minor modifications where the manufacturer self-certifies that safety and effectiveness aren't affected; review targets are shorter.

Cequr SA files from Horw Luzern, Switzerland. The Special pathway here produced a roughly seven-month clock, which is unusually long for the category and may reflect additional questions from FDA despite the Special designation.