510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K202690Substantially Equivalent

Remunity Pump for Remodulin (treprostinil) Injection

Deka Research & Development Corp., Manchester NH / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K202690 is the FDA 510(k) clearance record for Remunity Pump for Remodulin (treprostinil) Injection, a class II device, cleared for Deka Research and Development on under FDA product code QJY (Infusion Pump, Drug Specific, Pharmacy-Filled). FDA's definition for product code QJY reads: "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". FDA records list 28 510(k) clearances for Deka Research and Development, from to . As of , FDA records show no recalls naming K202690.

Clearance record

Decision date
Received
(106 days to decision)
Product code
QJY Infusion Pump, Drug Specific, Pharmacy-Filled
Regulation
21 CFR 880.5725
Device class
Class II
Review panel
General Hospital
Applicant
Deka Research and Development 340 Commercial St., Manchester NH
510(k) summary
Summary PDF
Third party review
No

Clearances, product code QJY

Trailing 12 months

FDA records hold no clearances under product code QJY in the trailing twelve months.

FDA records show no clearances under product code QJY in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code QJY, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260