Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
FRN — Predicate Candidate Screening
849 FDA 510(k) clearances under this product code; the 50 most recent screened below.
83 daysmedian FDA review time
284 days90th percentile
849clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K253703 | RemunityPRO+ Pump for Remodulin® (treprostinil) Injection | Deka R&D Corp | 2026-07-24 | 242 | 0 |
| K252015 | FreedomEdge Infusion System; High-Flo SubQ Needle Set; Preci | Koru Medical Systems, Inc. | 2026-01-28 | 215 | 0 |
| K251640 | SIGMA Spectrum Infusion Pump with Master Drug Library | Baxter Healthcare Corporation | 2025-07-28 | 60 | 1 |
| K251636 | Spectrum IQ Infusion System with Dose IQ Safety Software (35 | Baxter Healthcare Corporation | 2025-07-28 | 60 | 1 |
| K242752 | MRidium 3870 MRI Infusion Pump System (3870) | Iradimed Corporation | 2025-05-28 | 258 | 0 |
| K243855 | BD Alaris Infusion System with Guardrails Suite MX | Carefusion 303, Inc. | 2025-04-25 | 130 | 0 |
| K242114 | Plum Solo™ Precision IV Pump | Icu Medical, Inc. | 2025-04-02 | 257 | 3 |
| K242115 | Plum Duo™ Precision IV Pump | Icu Medical, Inc. | 2025-04-02 | 257 | 2 |
| K250357 | RemunityPRO™ Pump for Remodulin® (treprostinil) Injection | Deka Research & Development Corp. | 2025-03-11 | 32 | 0 |
| K241736 | Remunity 2.0 Pump for Remodulin (treprostinil) Injection | Deka Research and Development Corp. | 2025-01-16 | 213 | 0 |
| K242735 | Belmont Rapid Infuser, RI-2 (Rapid Infuser RI-2, 1000 ml/min | Belmont Medical Technologies | 2024-12-23 | 103 | 2 |
| K242660 | Curlin 8000 Ambulatory Infusion System; Enterprise Solution | Zevex, Inc. | 2024-10-03 | 29 | 0 |
| K242390 | Novum IQ Syringe Pump (40800BAXUS) | Baxter Healthcare Corporation | 2024-09-05 | 24 | 3 |
| K232793 | Curlin 8000 Ambulatory Infusion System; Enterprise Solution | Zevex, Inc. | 2024-05-17 | 249 | 0 |
| K211122 | Novum IQ Large Volume Pump | Baxter Healthcare Corporation | 2024-03-29 | 1079 | 3 |
| K231918 | Freedom60 Infusion Pump; High-Flo Subcutaneous Needle Sets; | Koru Medical Systems | 2023-11-03 | 127 | 0 |
| K230083 | SAFIRA | Medovate Limited | 2023-10-31 | 293 | 0 |
| K223607 | Plum Duo™ Infusion System | Icu Medical, Inc. | 2023-08-24 | 265 | 6 |
| K211218 | BD Alaris System with Guardrails Suite MX v12.1.2 | Carefusion 303, Inc. | 2023-07-21 | 819 | 16 |
| K230041 | Spectrum IQ Infusion System with Dose IQ Safety Software | Baxter Healthcare Corporation | 2023-03-31 | 84 | 7 |
| K230022 | Baxter SIGMA Spectrum Infusion Pump with Master Drug Library | Baxter Healthcare Corporation | 2023-03-31 | 86 | 5 |
| K213744 | Avoset Infusion Pump System | Eitan Medical , Ltd. | 2023-03-10 | 466 | 0 |
| K222048 | Spectrum IQ Infusion System with Dose IQ Safety Software | Baxter Healthcare Corporation | 2022-09-06 | 56 | 0 |
| K211125 | Novum IQ Syringe Pump | Baxter Healthcare Corporation | 2022-08-30 | 502 | 1 |
| K214045 | FreedomEdge Syringe Infusion System | Repro-Medical System, Inc., Dba Koru Medical Systems | 2022-04-29 | 123 | 0 |
| K220417 | Spectrum IQ Infusion System with Dose IQ Safety Software | Baxter Healthcare Corporation | 2022-04-29 | 74 | 0 |
| K210074 | Agilia SP Infusion System, Agilia SP MC WIFI Infusion Pump, | Fresenius Kabi AG | 2022-03-01 | 413 | 0 |
| K210073 | Agilia VP Infusion System, Agilia VP MC WIFI Infusion Pump, | Fresenius Kabi AG | 2022-03-01 | 413 | 0 |
| K200176 | FREEDOM Integrated Syringe Infusion System | Repro-Med Systems, Inc. Dba Koru Medical Systems | 2021-12-15 | 691 | 0 |
| K211206 | FreedomEdge(R) Syringe Infusion System | Repro-Medical System, Inc., Dba Koru Medical Systems | 2021-11-09 | 201 | 0 |
| K192860 | Sapphire Infusion Pump, Sapphire administration sets | Q Core Medical , Ltd. | 2020-11-19 | 412 | 1 |
| K183311 | Ivenix Infusion System (IIS) | Ivenix, Inc. | 2019-06-07 | 190 | 24 |
| K190182 | Unity Subcutaneous Delivery System for Remodulin | DEKA Research & Development | 2019-05-06 | 94 | 0 |
| K172653 | Power Infuser | ZOLL Medical Corporation | 2018-07-18 | 316 | 0 |
| K172831 | Perfusor® Space Syringe Infusion Pump System | B.Braun Medical, Inc. | 2018-06-12 | 267 | 3 |
| K173084 | Spectrum IQ Infusion System, Dose IQ Safety Software | Baxter Healthcare Corporation | 2018-05-11 | 224 | 4 |
| K162613 | Integrated Catch-up Freedom Syringe Driver Infusion System | Repro-Med Systems, Inc. Dba Rms Medical Products | 2017-08-31 | 346 | 0 |
| K161469 | Plum 360(TM) Infusion System with MedNet/ Smart Card Plug an | Hospira, Inc. | 2017-03-28 | 305 | 4 |
| K161667 | Sapphire Infusion Pump | Q Core Medical , Ltd. | 2017-03-27 | 284 | 0 |
| K143369 | MRidium 3860+ MRI infusion Pump/ Monitoring System | Iradimed Corporation | 2016-12-15 | 751 | 1 |
| K153599 | Concert Medical Hands-Free Syringe (HFS) | Concert Medical, LLC | 2016-09-01 | 260 | 0 |
| K153193 | Halo II Ambulatory Infusion System (also with trade names Ni | Zyno Medical, LLC | 2016-08-30 | 301 | 4 |
| K151255 | Navigator Aesthetic Delivery System | Carticept Medical, Inc. | 2015-12-30 | 232 | 0 |
| K142596 | Infusomat Space Volumetric Infusion Pump | B.Braun Medical, Inc. | 2015-06-18 | 276 | 2 |
| K141789 | PLUM 360 INFUSION SYSTEM WITH HOSPIRA MEDNET, SMART CARD PLU | Hospira, Inc. | 2015-01-16 | 198 | 3 |
| K141389 | SAPPHIRE INFUSION PUMP | Q Core Medical , Ltd. | 2014-12-11 | 198 | 0 |
| K140783 | HALO AMBULATORY INFUSION SYSTEM | Zyno Medical, LLC | 2014-10-17 | 200 | 2 |
| K133532 | ALARIS SYSTEM WITH GUARDRAILS SUITE MX | Carefusion 303, Inc. | 2014-08-21 | 276 | 29 |
| K141654 | THE BELMONT RAPID INFUSER | Belmont Instrument Corporation | 2014-07-18 | 28 | 0 |
| K141102 | HOSPIRA MEDNET MEDICATION MANAGEMENT SUITE | Hospira, Inc. | 2014-07-08 | 70 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda