Cleared Traditional

Unity Subcutaneous Infusion System for Remodulin

K191313 · DEKA Research & Development · General Hospital
Feb 2020
Decision
282d
Days
Class 2
Risk

About This 510(k) Submission

K191313 is an FDA 510(k) clearance for the Unity Subcutaneous Infusion System for Remodulin, a Infusion Pump, Drug Specific, Pharmacy-filled (Class II — Special Controls, product code QJY), submitted by DEKA Research & Development (Manchester, US). The FDA issued a Cleared decision on February 21, 2020, 282 days after receiving the submission on May 15, 2019. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5725.

Submission Details

510(k) Number K191313 FDA.gov
FDA Decision Cleared SESE
Date Received May 15, 2019
Decision Date February 21, 2020
Days to Decision 282 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF

Device Classification

Product Code QJY — Infusion Pump, Drug Specific, Pharmacy-filled
Device Class Class II — Special Controls
CFR Regulation 21 CFR 880.5725
Definition A Pharmacy-filled, Drug Specific Infusion System Is A Prescription Device Intended For Delivery Of A Specific Drug In Accordance With The Fda Approved Labeling And May Be Filled At A Location Other Than Point Of Care.