Unity Subcutaneous Infusion System for Remodulin

by Deka Research and Development 510(k)

Active United States

510(k) K191313

Regulatory status

as of 29 Oct 2026

Region	Authorization	Number	Date	Status
United States	FDA 510(k)SESE Substantially Equivalent · Traditional	NumberK191313	Date21 Feb 2020Cleared	StatusActive

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

510(k)

510(k) Number: K191313
FDA Product Code: QJY
FDA applicant: DEKA Research & Development

Device Class: Class II
Regulation: 21 CFR Part 880.5725
Advisory Committee: General Hospital
FDA Decision: SESE Substantially Equivalent

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