510(k) · Cleared
ClearedRemunity Pump for Remodulin (treprostinil) Injection
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Deka Research and Development · QJY Infusion Pump, Drug Specific, Pharmacy-Filled
Cleared on Dec 30, 2020 as substantially equivalent to K191313 (DEKA Research & Development, 2020) after a 106-day review. Its family tree reaches back 3 generations to 2005. 1 later device descends from it.
- Decided
- Dec 30, 2020
- Review
- 106 days
- Class
- Class II
- Product code
- QJY
- 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 backK191313 Unity Subcutaneous Infusion System for RemodulinDEKA Research & Development · 2020
- This deviceK202690 Remunity Pump for Remodulin (treprostinil) InjectionDeka Research and Development · 2020
- Descendant · cites it directly · 0 of its ownK240256 Remunity SystemDeka Research and Development · 2024
Most influential descendants
Showing 1 of 1 · See all- K240256Remunity SystemDeka Research and Development · 2024 · 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 | K191313 | Unity Subcutaneous Infusion System for Remodulin | DEKA Research & Development | 2020 | — |
| 0 (this device) | K202690 | Remunity Pump for Remodulin (treprostinil) Injection | Deka Research and Development | 2020 | — |
| +1 | K240256 | Remunity System | Deka Research and Development | 2024 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2024 | 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 QJY? 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 QJY device
- #1 K243354 Remunity Systemscore 9.0 · 3 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 |
|---|---|---|---|
| * | K191313 | Unity Subcutaneous Infusion System for RemodulinSummary page 4…rug specific, pharmacy-filled Class II Device Panel: General Hospital Predicate Device Unity Subcutaneous Delivery System for Remodulin K191313. No reference devices are used in this submission. Device Description The Remunity Subcutaneous Delivery System for Remodulin®… | 2020 |
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 |
|---|---|---|---|
| K240256 | Remunity System | 2024 | 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 15 years and passes through 3 companies; a new generation was cleared every 10 months on median.
- 1 of the 3 ancestors has a recall of any class.
- Of its descendants, K240256 (Deka Research and Development, 2024) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K191313.
How does its category compare?
All QJY devicesQJY Infusion Pump, Drug Specific, Pharmacy-Filled: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, this device’s year, is highlighted.
FDA decisions per year · QJY
2in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · QJY
Too few QJY 510(k)s in any year since 2007 to give a median.
Recalls per year · QJY
No recall names QJY since 2007.
Adverse event reports per year · QJY
154in 2025
MAUDE reports naming product code QJY, 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 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 2 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 4 |
| 2022 | 0 | — | 0 | 22 |
| 2023 | 0 | — | 0 | 61 |
| 2024 | 2 | — | 0 | 43 |
| 2025 | 0 | — | 0 | 154 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Remunity Subcutaneous Infusion System (the Remunity System) is intended for continuous subcutaneous delivery of Remodulin® (treprostinil) Injection for use in adults (greater than 22 years of age).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K202690 · printed Nov 6, 2026
Cite this page
510(k) Report. “K202690: Remunity Pump for Remodulin (treprostinil) Injection.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K202690
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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