510(k) · Cleared
ClearedRemunityPRO™ Pump for Remodulin® (treprostinil) Injection
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Deka Research & Development Corp. · FRN Pump, Infusion
Cleared on Mar 11, 2025 as substantially equivalent to K241736 (Deka Research and Development Corp., 2025) after a 32-day review. Its family tree reaches back 3 generations to 2005. 1 later device descends from it.
- Decided
- Mar 11, 2025
- Review
- 32 days
- Class
- Class II
- Product code
- FRN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K051568 (2005). 1 later device descends from it, 1 citing it directly.
- Root · 3 generations backK051568 Cadd-MS 3 Ambulatory Infusion PumpSmiths Medical MD, Inc. · 2005 · Recalled
- 2 generations backK190182 Unity Subcutaneous Delivery System for RemodulinDEKA Research & Development · 2019
- 1 generation backK241736 Remunity 2.0 Pump for Remodulin (treprostinil) InjectionDeka Research and Development Corp. · 2025
- This deviceK250357 RemunityPRO™ Pump for Remodulin® (treprostinil) InjectionDeka Research & Development Corp. · 2025
- Descendant · cites it directly · 0 of its ownK253703 RemunityPRO+ Pump for Remodulin® (treprostinil) InjectionDeka R&D Corp · 2026
Most influential descendants
Showing 1 of 1 · See all- K253703RemunityPRO+ Pump for Remodulin® (treprostinil) InjectionDeka R&D Corp · 2026 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K051568 | Cadd-MS 3 Ambulatory Infusion Pump | Smiths Medical MD, Inc. | 2005 | 2 |
| −2 | K190182 | Unity Subcutaneous Delivery System for Remodulin | DEKA Research & Development | 2019 | — |
| −1 | K241736 | Remunity 2.0 Pump for Remodulin (treprostinil) Injection | Deka Research and Development Corp. | 2025 | — |
| 0 (this device) | K250357 | RemunityPRO™ Pump for Remodulin® (treprostinil) Injection | Deka Research & Development Corp. | 2025 | — |
| +1 | K253703 | RemunityPRO+ Pump for Remodulin® (treprostinil) Injection | Deka R&D Corp | 2026 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2026 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in FRN? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new FRN device
- #1 K253703 RemunityPRO+ Pump for Remodulin®…score 12.6 · 4 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K241736 | Remunity 2.0 Pump for Remodulin (treprostinil) InjectionSummary page 5…II Device Panel: General Hospital Predicate Device The predicate device is the Remunity® 2.0 Pump for Remodulin® (treprostinil) Injection, K241736, cleared on January 16, 2025. The predicate device has not been subject to a design-related recall. Device Description The Remu… | 2025 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K253703 | RemunityPRO+ Pump for Remodulin® (treprostinil) Injection | 2026 | 0 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 20 years and passes through 4 companies; a new generation was cleared every 5.7 years on median.
- 1 of the 3 ancestors has a recall of any class.
- Of its descendants, K253703 (Deka R&D Corp, 2026) has gone furthest, with 0 descendants of its own.
How does its category compare?
All FRN devicesFRN Pump, Infusion: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, this device’s year, is highlighted.
FDA decisions per year · FRN
8in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · FRN
172in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FRN
7in 2025
Class I (37 since 2007) Class II/III not classified
Adverse event reports per year · FRN
52,792in 2025
MAUDE reports naming product code FRN, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 12 | 102 | 15 | 1,086 |
| 2008 | 8 | 89 | 24 | 8,261 |
| 2009 | 9 | 66 | 102 | 1,952 |
| 2010 | 3 | 93 | 37 | 6,133 |
| 2011 | 3 | 103 | 69 | 41,367 |
| 2012 | 4 | 217 | 42 (2) | 15,482 |
| 2013 | 6 | 312 | 22 (3) | 40,082 |
| 2014 | 6 | 172 | 4 (3) | 94,180 |
| 2015 | 3 | 232 | 5 | 26,742 |
| 2016 | 3 | 301 | 7 (1) | 16,560 |
| 2017 | 3 | 305 | 13 | 12,060 |
| 2018 | 3 | 267 | 1 | 16,591 |
| 2019 | 2 | — | 18 (1) | 15,850 |
| 2020 | 1 | — | 16 (5) | 94,186 |
| 2021 | 2 | — | 3 (2) | 199,342 |
| 2022 | 6 | 268 | 2 | 888,020 |
| 2023 | 7 | 265 | 16 (10) | 165,838 |
| 2024 | 5 | 103 | 9 (4) | 57,730 |
| 2025 | 8 | 172 | 7 (4) | 52,792 |
| 2026 | 2 | — | 11 (2) | — |
What is it indicated for?
The RemunityPRO™ Pump for Remodulin® (treprostinil) Injection (the RemunityPRO System) is intended for
continuous subcutaneous delivery of Remodulin (treprostinil) Injection for use in patients, ages 17 and older.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K250357 · printed Nov 4, 2026
Cite this page
510(k) Report. “K250357: RemunityPRO™ Pump for Remodulin® (treprostinil) Injection.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K250357
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026