510(k) · Cleared
ClearedUnity Subcutaneous Infusion System for Remodulin
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
DEKA Research & Development · QJY Infusion Pump, Drug Specific, Pharmacy-Filled
Cleared on Feb 21, 2020 as substantially equivalent to K190182 (DEKA Research & Development, 2019) after a 282-day review. Its family tree reaches back 2 generations to 2005. 3 later devices descend from it.
- Decided
- Feb 21, 2020
- Review
- 282 days
- Class
- Class II
- Product code
- QJY
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K051568 (2005). 3 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK051568 Cadd-MS 3 Ambulatory Infusion PumpSmiths Medical MD, Inc. · 2005 · Recalled
- 1 generation backK190182 Unity Subcutaneous Delivery System for RemodulinDEKA Research & Development · 2019
- This deviceK191313 Unity Subcutaneous Infusion System for RemodulinDEKA Research & Development · 2020
- Descendant · cites it directly · 1 of its ownK202690 Remunity Pump for Remodulin (treprostinil) InjectionDeka Research and Development · 2020
- Descendant · cites it directly · 0 of its ownK243354 Remunity SystemDeka Research & Development Corp. · 2024
- Descendant · 2 generations on · 0 of its ownK240256 Remunity SystemDeka Research and Development · 2024
Most influential descendants
Showing 3 of 3 · See all- K202690Remunity Pump for Remodulin (treprostinil) InjectionDeka Research and Development · 2020 · cites it directly1descendant
- K243354Remunity SystemDeka Research & Development Corp. · 2024 · cites it directly0descendants
- K240256Remunity SystemDeka Research and Development · 2024 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K051568 | Cadd-MS 3 Ambulatory Infusion Pump | Smiths Medical MD, Inc. | 2005 | 2 |
| −1 | K190182 | Unity Subcutaneous Delivery System for Remodulin | DEKA Research & Development | 2019 | — |
| 0 (this device) | K191313 | Unity Subcutaneous Infusion System for Remodulin | DEKA Research & Development | 2020 | — |
| +1 | K202690 | Remunity Pump for Remodulin (treprostinil) Injection | Deka Research and Development | 2020 | — |
| +1 | K243354 | Remunity System | Deka Research & Development Corp. | 2024 | — |
| +2 | K240256 | Remunity System | Deka Research and Development | 2024 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 1 | 0 |
| 2024 | 2 | 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 |
|---|---|---|---|
| * | K190182 | Unity Subcutaneous Delivery System for RemodulinSummary page 4…cy-filled Class: II Device Panel: General Hospital Predicate Device Unity Subcutaneous Delivery System for Remodulin® K190182. No reference devices are used in this submission. Device Description The Unity Subcutaneous Delivery System for Remodulin® (Uni… | 2019 |
What descends from it? (3)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 2 companies; a new generation was cleared every 13.5 years on median.
- 1 of the 2 ancestors has a recall of any class.
- Of its descendants, K202690 (Deka Research and Development, 2020) has gone furthest, with 1 descendant of its own.
- 1 other device also cites its predicate K190182.
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 Unity Subcutaneous Infusion System (the Unity 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/K191313 · printed Nov 6, 2026
Cite this page
510(k) Report. “K191313: Unity Subcutaneous Infusion System for Remodulin.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K191313
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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