510(k) · Cleared
ClearedRemunity System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Deka Research & Development Corp. · QJY Infusion Pump, Drug Specific, Pharmacy-Filled
Cleared on Nov 27, 2024 as substantially equivalent to K191313 (DEKA Research & Development, 2020) after a 29-day review. Its family tree reaches back 3 generations to 2005.
- Decided
- Nov 27, 2024
- Review
- 29 days
- Class
- Class II
- Product code
- QJY
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K051568 (2005). No later device cites it as a predicate yet.
- 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 deviceK243354 Remunity SystemDeka Research & Development Corp. · 2024
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) | K243354 | Remunity System | Deka Research & Development Corp. | 2024 | — |
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 K240256 Remunity Systemscore 8.4 · 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 |
|---|---|---|---|
| * | K191313 | Unity Subcutaneous Infusion System for RemodulinSummary page 5…Hospital Predicate Device(s) The predicate device is the Remunity Subcutaneous Delivery System for Remodulin®, which was previously cleared under premarket application K191313 on February 12, 2020. Device Description The Remunity Subcutaneous Delivery System for Remodulin® (Remunity System) is a wearab… | 2020 |
| † | K991759 | Maersk Medical Contour Infusion Set | 1999 |
| † | K162812 | Unomedical Comfort Subcutaneous Infusion Set, Unomedical Comfort Short Subcutaneous… | 2017 |
| † | K042172 | Cleo 90 Infusion Set | 2004 |
| † | K192647 | neria guard Infusion Set | 2019 |
What descends from it?
No later submission names this one as a predicate yet.
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 19 years and passes through 3 companies; a new generation was cleared every 4.8 years on median.
- 1 of the 3 ancestors has a recall of any class.
- 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. 2024, 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® Pump for Remodulin® (treprostinil) Injection (the Remunity System) is intended for continuous subcutaneous delivery of Remodulin (treprostinil) Injection for use in adults (greater than 22 years old).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K243354 · printed Nov 6, 2026
Cite this page
510(k) Report. “K243354: Remunity System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K243354
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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