RemunityPRO+ Pump for Remodulin® (treprostinil) Injection— 510(k) K253703
Substantially EquivalentDeka R&D Corp
FDA 510(k) clearance K253703 for RemunityPRO+ Pump for Remodulin® (treprostinil) Injection, Substantially Equivalent on 2026-07-24. Applicant: Deka R&D Corp. Device class: 2.
Summary
Deka R&D's RemunityPRO+ Pump for Remodulin (treprostinil) Injection is filed under FRN, infusion pumps. The drug reference comes from the device name, and the record doesn't give pump specs.
Class II, 21 CFR 880.5725. General Hospital is both the classification panel and the review panel, and it came in as a Traditional 510(k).
Deka filed from Manchester, New Hampshire. The decision came 242 calendar days after receipt (November 24, 2025 to July 24, 2026).
Clearance details
- Applicant
- Deka R&D Corp
- Product code
- Product code FRN
- Device class
- Class 2
- Regulation
- 21 CFR 880.5725
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Manchester, NH, US
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Adverse events under product code FRN
product code FRN- Death
- 540
- Injury
- 6,178
- Malfunction
- 1,464,165
- Other
- 52
- Total
- 1,470,935
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.