Cleared Traditional

Remunity Pump for Remodulin (treprostinil) Injection

K202690 · Deka Research and Development · General Hospital
Dec 2020
Decision
106d
Days
Class 2
Risk

About This 510(k) Submission

K202690 is an FDA 510(k) clearance for the Remunity Pump for Remodulin (treprostinil) Injection, a Infusion Pump, Drug Specific, Pharmacy-filled (Class II — Special Controls, product code QJY), submitted by Deka Research and Development (Manchester, US). The FDA issued a Cleared decision on December 30, 2020, 106 days after receiving the submission on September 15, 2020. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5725.

Submission Details

510(k) Number K202690 FDA.gov
FDA Decision Cleared SESE
Date Received September 15, 2020
Decision Date December 30, 2020
Days to Decision 106 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.