510(k) Report

510(k) · Cleared

Cleared

Unity Subcutaneous Delivery System for Remodulin

K190182510(k) TraditionalCleared May 6, 201994-day reviewClass II21 CFR 880.5725

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

DEKA Research & Development · FRN Pump, Infusion

Cleared on May 6, 2019 as substantially equivalent to K051568 (Smiths Medical MD, Inc., 2005) after a 94-day review. Its family tree reaches back 1 generation to 2005. 7 later devices descend from it.

Decided
May 6, 2019
Review
94 days
Class
Class II
Product code
FRN
Recalls
None
Predicates
1

Its longest line of descent runs back 1 generation to K051568 (2005). 7 later devices descend from it, 2 citing it directly.

Descendants, by year cleared 2020: 2 descendants cleared2025: 2 descendants cleared2024: 2 descendants cleared2026: 1 descendant clearedK051568 · Cadd-MS 3 Ambulatory Infusion Pump · Smiths Medical MD, Inc. · 2005 · recalled20052010201520202025
Descendants, by generation 1 generation forward: 2 descendants2 generations forward: 3 descendants3 generations forward: 2 descendants K051568 · Cadd-MS 3 Ambulatory Infusion Pump · Smiths Medical MD, Inc. · 2005 · recalled0
  1. Root · 1 generation backK051568 Cadd-MS 3 Ambulatory Infusion PumpSmiths Medical MD, Inc. · 2005 · Recalled
  2. This deviceK190182 Unity Subcutaneous Delivery System for RemodulinDEKA Research & Development · 2019
  3. Descendant · cites it directly · 3 of its ownK191313 Unity Subcutaneous Infusion System for RemodulinDEKA Research & Development · 2020
  4. Descendant · cites it directly · 2 of its ownK241736 Remunity 2.0 Pump for Remodulin (treprostinil) InjectionDeka Research and Development Corp. · 2025
  5. Descendant · 2 generations on · 1 of its ownK250357 RemunityPRO™ Pump for Remodulin® (treprostinil) InjectionDeka Research & Development Corp. · 2025
  6. Descendant · 2 generations on · 1 of its ownK202690 Remunity Pump for Remodulin (treprostinil) InjectionDeka Research and Development · 2020
  7. Descendant · 3 generations on · 0 of its ownK253703 RemunityPRO+ Pump for Remodulin® (treprostinil) InjectionDeka R&D Corp · 2026

Showing 5 of 7 descendants. See all descendants

Descendants cleared per year

2020: 22024: 22025: 22026: 1
2020high 2 (2020) · low 0 (2021)2026

Most influential descendants

Showing 5 of 7 · See all
  • K191313Unity Subcutaneous Infusion System for RemodulinDEKA Research & Development · 2020 · cites it directly3descendants
  • K241736Remunity 2.0 Pump for Remodulin (treprostinil) InjectionDeka Research and Development Corp. · 2025 · cites it directly2descendants
  • K250357RemunityPRO™ Pump for Remodulin® (treprostinil) InjectionDeka Research & Development Corp. · 2025 · 2 generations on1descendant
  • K202690Remunity Pump for Remodulin (treprostinil) InjectionDeka Research and Development · 2020 · 2 generations on1descendant
  • K253703RemunityPRO+ Pump for Remodulin® (treprostinil) InjectionDeka R&D Corp · 2026 · 3 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K051568Cadd-MS 3 Ambulatory Infusion PumpSmiths Medical MD, Inc.20052
0 (this device)K190182Unity Subcutaneous Delivery System for RemodulinDEKA Research & Development2019—
+1K191313Unity Subcutaneous Infusion System for RemodulinDEKA Research & Development2020—
+1K241736Remunity 2.0 Pump for Remodulin (treprostinil) InjectionDeka Research and Development Corp.2025—
+2K250357RemunityPRO™ Pump for Remodulin® (treprostinil) InjectionDeka Research & Development Corp.2025—
+2K202690Remunity Pump for Remodulin (treprostinil) InjectionDeka Research and Development2020—
+3K253703RemunityPRO+ Pump for Remodulin® (treprostinil) InjectionDeka R&D Corp2026—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
202020
202420
202520
202610
FIG. 1 — Lineage of K190182, 2005–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K253703 RemunityPRO+ Pump for Remodulin®…score 12.6 · 4 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) 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.

TypeNumberDeviceApplicantDecidedRecalls
*K051568Cadd-MS 3 Ambulatory Infusion Pump
Summary page 4
…Class II Device Panel: General Hospital Devices Branch Predicate Device CADD-MS3 Ambulatory Infusion Pump (Smiths Medical) K051568. No reference devices are used in this submission. Device Description The Unity Subcutaneous Delivery System for Remodulin® (Uni…
Smiths Medical MD, Inc.20052

Also cleared against K051568: 2 other devices →

What descends from it? (7)

2 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K191313Unity Subcutaneous Infusion System for RemodulinDEKA Research & Development20203
K241736Remunity 2.0 Pump for Remodulin (treprostinil) InjectionDeka Research and Development Corp.20252

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?

  • Its one ancestor has a recall.
  • Of its descendants, K191313 (DEKA Research & Development, 2020) has gone furthest, with 3 descendants of its own.
  • 2 other devices also cite its predicate K051568.

How does its category compare?

All FRN devices

FRN Pump, Infusion: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, this device’s year, is highlighted.

FDA decisions per year · FRN

8in 2025

2007: 122008: 82009: 92010: 32011: 32012: 42013: 62014: 62015: 32016: 32017: 32018: 32019: 22020: 12021: 22022: 62023: 72024: 52025: 82026 (partial year): 2
2007high 12 (2007) · low 1 (2020)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · FRN

172in 2025

2007: 102 days median2008: 89 days median2009: 66 days median2010: 93 days median2011: 103 days median2012: 217 days median2013: 312 days median2014: 172 days median2015: 232 days median2016: 301 days median2017: 305 days median2018: 267 days median2022: 268 days median2023: 265 days median2024: 103 days median2025: 172 days median
2007high 312 (2013) · low 66 (2009)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · FRN

7in 2025

2007: 152008: 242009: 1022010: 372011: 692012: 42, 2 Class I2013: 22, 3 Class I2014: 4, 3 Class I2015: 52016: 7, 1 Class I2017: 132018: 12019: 18, 1 Class I2020: 16, 5 Class I2021: 3, 2 Class I2022: 22023: 16, 10 Class I2024: 9, 4 Class I2025: 7, 4 Class I2026 (partial year): 11, 2 Class I
2007high 102 (2009) · low 1 (2018)2026

Class I (37 since 2007) Class II/III not classified

Adverse event reports per year · FRN

52,792in 2025

2007: 1,0862008: 8,2612009: 1,9522010: 6,1332011: 41,3672012: 15,4822013: 40,0822014: 94,1802015: 26,7422016: 16,5602017: 12,0602018: 16,5912019: 15,8502020: 94,1862021: 199,3422022: 888,0202023: 165,8382024: 57,7302025: 52,792
2007high 888,020 (2022) · low 1,086 (2007)2025

MAUDE reports naming product code FRN, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
200712102151,086
2008889248,261
20099661021,952
2010393376,133
201131036941,367
2012421742 (2)15,482
2013631222 (3)40,082
201461724 (3)94,180
20153232526,742
201633017 (1)16,560
201733051312,060
20183267116,591
20192—18 (1)15,850
20201—16 (5)94,186
20212—3 (2)199,342
202262682888,020
2023726516 (10)165,838
202451039 (4)57,730
202581727 (4)52,792
20262—11 (2)—

What is it indicated for?

The Unity Subcutaneous Delivery System for Remodulin® (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.

Also cleared against K051568

2 other devices cite the same predicate.

  • K230718UTC 3mL Medication CartridgeGilero, LLC · 2023
  • K201634RG 3ml Medication CartridgeChengdu Shifeng Medical Technology Co., Ltd. · 2021

More from DEKA Research & Development

3 FDA decisions under this applicant name. See the company

  • K191313Unity Subcutaneous Infusion System for RemodulinDEKA Research & Development · 2020
  • K153760Volumetric Infusion ControllerDEKA Research & Development · 2016

Recent decisions in FRN

The FRN category page

  • K253703RemunityPRO+ Pump for Remodulin® (treprostinil) InjectionDeka R&D Corp · 2026
  • K252015FreedomEdge Infusion System; High-Flo SubQ Needle Set; Precision Flow Rate TubingKoru Medical Systems, Inc. · 2026
  • K251636Spectrum IQ Infusion System with Dose IQ Safety Software (3570009)Baxter Healthcare Corporation · 20251 recall
  • K251640SIGMA Spectrum Infusion Pump with Master Drug LibraryBaxter Healthcare Corporation · 20251 recall
  • K242752MRidium 3870 MRI Infusion Pump System (3870)Iradimed Corporation · 2025

https://510kreport.com/device/K190182 · printed Nov 4, 2026

Cite this page

510(k) Report. “K190182: Unity Subcutaneous Delivery System for Remodulin.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K190182

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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