Chrysalis Intelligence · Product Codes · FRN

FRN · Pump, Infusion

General Hospital · 31 clearances · 16 unique sponsors

← Library Overview New Filings 510(k) Explorer Recalls Explorer All Sponsors All Product Codes Orphan Products Signals
Device class
Class II
Regulation 880.5725
Total clearances
31
2020-11-19 → 2026-07-24
Last 12 months
2
Unique sponsors
16
Classification details
Medical specialty
General Hospital
Review panel
HO
Regulation number
880.5725
Implant
N
Life-sustain / support
N
GMP exempt
N
Third-party review
N
Trend

Clearance volume by quarter

Players

Top sponsors in this product code

Sponsor Clearances Last 12 mo Most recent
Baxter Healthcare Corporation 9 0 2025-07-28
Icu Medical, Inc. 3 0 2025-04-02
Zevex, Inc. 2 0 2024-10-03
Carefusion 303, Inc. 2 0 2025-04-25
Fresenius Kabi AG 2 0 2022-03-01
Koru Medical Systems, Inc. 2 1 2026-01-28
Repro-Medical System, Inc., Dba Koru Medical Systems 2 0 2022-04-29
Repro-Med Systems, Inc. Dba Koru Medical Systems 1 0 2021-12-15
Deka Research and Development Corp. 1 0 2025-01-16
Belmont Medical Technologies 1 0 2024-12-23
Medovate Limited 1 0 2023-10-31
Eitan Medical , Ltd. 1 0 2023-03-10
Q Core Medical , Ltd. 1 0 2020-11-19
Iradimed Corporation 1 0 2025-05-28
Deka R&D Corp 1 1 2026-07-24
Deka Research & Development Corp. 1 0 2025-03-11
Reimbursement

Likely billing codes (AI-inferred · verify with billing)

Healthcare providers using this device would typically bill under these HCPCS Level II (alphanumeric) or CPT (5-digit) codes. Mapping inferred from device function by Claude Haiku; official descriptions pulled from the CMS HCPCS April 2026 quarterly file where available. Always verify with billing/coding teams before relying on these.

CodeTypeDescriptionConfidenceRationale
E1520 HCPCS Heparin infusion pump for hemodialysis ✓ CMS-verified description High Standard HCPCS code for infusion pump rental or supply
36640 CPT — Medium Vascular access procedure code when pump placement/setup is billable
Pulse

Most recent 510(k) clearances

DateK-numberSponsorDevice
2026-07-24 K253703 Deka R&D Corp RemunityPRO+ Pump for Remodulin® (treprostinil) Injection
2026-01-28 K252015 Koru Medical Systems, Inc. FreedomEdge Infusion System; High-Flo SubQ Needle Set; Precision Flow Rate Tubing
2025-07-28 K251640 Baxter Healthcare Corporation SIGMA Spectrum Infusion Pump with Master Drug Library
2025-07-28 K251636 Baxter Healthcare Corporation Spectrum IQ Infusion System with Dose IQ Safety Software (3570009)
2025-05-28 K242752 Iradimed Corporation MRidium 3870 MRI Infusion Pump System (3870)
2025-04-25 K243855 Carefusion 303, Inc. BD Alaris Infusion System with Guardrails Suite MX
2025-04-02 K242115 Icu Medical, Inc. Plum Duo™ Precision IV Pump
2025-04-02 K242114 Icu Medical, Inc. Plum Solo™ Precision IV Pump
2025-03-11 K250357 Deka Research & Development Corp. RemunityPRO™ Pump for Remodulin® (treprostinil) Injection
2025-01-16 K241736 Deka Research and Development Corp. Remunity 2.0 Pump for Remodulin (treprostinil) Injection
2024-12-23 K242735 Belmont Medical Technologies Belmont Rapid Infuser, RI-2 (Rapid Infuser RI-2, 1000 ml/min); Belmont Rapid Infuser, RI-2 (Rapid Infuser RI-2, 750 ml/min)
2024-10-03 K242660 Zevex, Inc. Curlin 8000 Ambulatory Infusion System; Enterprise Solution (ES) Software; Curlin 380-series Administration Sets
2024-09-05 K242390 Baxter Healthcare Corporation Novum IQ Syringe Pump (40800BAXUS)
2024-05-17 K232793 Zevex, Inc. Curlin 8000 Ambulatory Infusion System; Enterprise Solution (ES) Software; Curlin 380-Series Adminstration Sets
2024-03-29 K211122 Baxter Healthcare Corporation Novum IQ Large Volume Pump
2023-11-03 K231918 Koru Medical Systems Freedom60 Infusion Pump; High-Flo Subcutaneous Needle Sets; Precision Flow Rate Tubing; High-Flo Super26 Subcutaneous Needle Sets; Freedom60 Pre-Filled Syringe Adapter
2023-10-31 K230083 Medovate Limited SAFIRA
2023-08-24 K223607 Icu Medical, Inc. Plum Duo™ Infusion System
2023-07-21 K211218 Carefusion 303, Inc. BD Alaris System with Guardrails Suite MX v12.1.2
2023-03-31 K230041 Baxter Healthcare Corporation Spectrum IQ Infusion System with Dose IQ Safety Software
2023-03-31 K230022 Baxter Healthcare Corporation Baxter SIGMA Spectrum Infusion Pump with Master Drug Library
2023-03-10 K213744 Eitan Medical , Ltd. Avoset Infusion Pump System
2022-09-06 K222048 Baxter Healthcare Corporation Spectrum IQ Infusion System with Dose IQ Safety Software
2022-08-30 K211125 Baxter Healthcare Corporation Novum IQ Syringe Pump
2022-04-29 K220417 Baxter Healthcare Corporation Spectrum IQ Infusion System with Dose IQ Safety Software
Data source: openFDA · Generated 2026-08-28 09:16 · Last ingest 2026-08-28T13:16:47.116226 · Pipeline: Chrysalis Intelligence