Product code FRN: 510(k) clearances and predicates
Product code FRN covers RemunityPRO+ Pump for Remodulin® (treprostinil) Injection. FDA lists 849 clearances under this code in the 510(k) index. This page summarizes recent clearance volume and names recent clearances by K number so you can pick predicates faster.
Clearance volume
849 clearances on file under product code FRN. Counts by year:
| Year | Clearances |
|---|---|
| 2022 | 6 |
| 2023 | 7 |
| 2024 | 5 |
| 2025 | 8 |
| 2026 so far | 2 |
Recent clearances
Newest FRN clearances in the FDA index, with applicant and decision date:
- K253703, RemunityPRO+ Pump for Remodulin® (treprostinil) Injection, applicant Deka R&D Corp, decided 2026-07-24. FDA record
- K252015, FreedomEdge Infusion System; High-Flo SubQ Needle Set; Precision Flow Rate Tubing, applicant Koru Medical Systems, Inc., decided 2026-01-28. FDA record
- K251640, SIGMA Spectrum Infusion Pump with Master Drug Library, applicant Baxter Healthcare Corporation, decided 2025-07-28. FDA record
- K251636, Spectrum IQ Infusion System with Dose IQ Safety Software (3570009), applicant Baxter Healthcare Corporation, decided 2025-07-28. FDA record
- K242752, MRidium 3870 MRI Infusion Pump System (3870), applicant Iradimed Corporation, decided 2025-05-28. FDA record
- K243855, BD Alaris Infusion System with Guardrails Suite MX, applicant Carefusion 303, Inc., decided 2025-04-25. FDA record
- K242115, Plum Duo Precision IV Pump, applicant Icu Medical, Inc., decided 2025-04-02. FDA record
- K242114, Plum Solo Precision IV Pump, applicant Icu Medical, Inc., decided 2025-04-02. FDA record
What this means for a regulatory watcher
Volume tells you how deep the predicate pool is. A code with steady yearly counts gives you many candidate predicates, which helps when one predicate has a recall or design gap. A code with a sharp recent rise means reviewers are seeing more of this device type, so substantial equivalence arguments need to track the newest cleared devices, not five year old ones. Related device names in recent clearances include FreedomEdge Infusion System; High-Flo SubQ Needle Set; Precision Flow Rate Tubing, SIGMA Spectrum Infusion Pump with Master Drug Library. Watch new FRN clearances as they post: each one is a possible predicate for your submission and a possible competitor worth reading.
FAQ
What is FDA product code FRN?
It is the three letter code FDA assigns to a device type in the 510(k) index. Recent FRN clearances include RemunityPRO+ Pump for Remodulin® (treprostinil) Injection.
How many 510(k) clearances use product code FRN?
849 at the time this page was generated, from openFDA records.
How do I find a predicate device under FRN?
Start with the recent K numbers listed above, then run the free predicate search to check substantial equivalence text and review history.
How do I track new FRN clearances?
Get 510(k) alerts filtered to this product code and read each new clearance as it posts.
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Data: U.S. FDA via openFDA (public domain). Not regulatory advice. Assume all results are unvalidated.