Panels › General Hospital › Product code FRN · Class 2
Pump, Infusion
Regulation 880.5725
2510(k)s in 12 months (849 all time)
24recalls in 12 months (724 all time)
672recalls that name a 510(k)
Top companies in FRN
| Company | 510(k)s | Recalls |
|---|---|---|
| Baxter Healthcare Corp | 51 | 128 |
| Hospira, Inc. | 12 | 129 |
| Stryker Instruments Div. of Stryker Corporation | 0 | 78 |
| Abbott Laboratories | 67 | 4 |
| Carefusion 303, Inc. | 4 | 61 |
| Icu Medical, Inc. | 4 | 43 |
| Smiths Medical Asd, Inc. | 1 | 42 |
| B.Braun Medical, Inc. | 11 | 22 |
| Y | 26 | 0 |
| Zevex International, Inc. | 0 | 25 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 24, 2025 | CareFusion 303, Inc. BD Alaris Pump Module REF 8100
The BD Alaris System with Guardrails Suite MX is a modular infusion pump and monitoring system for the continuous or intermittent administration of fluids to adult, ped Open, Classified |
FRN | K211218 |
| Feb 4, 2025 | Belmont Instrument LLC Belmont Medical 3-Spike Disposable Set used with the Belmont Rapid Infuser RI-2. Designed to be used in general operation in hospital or alternate care environments to provide warmed blood and fluids Open, Classified |
FRN | K242735 |
| Feb 4, 2025 | Fresenius Kabi USA, LLC Ivenix Infusion System (IIS), LVP Software LVP-SW-0005.
Indicated for use in a hospital and in outpatient care environments for the controlled administration of fluids through clinically accepted rou Open, Classified |
FRN | K183311 |
| Jan 8, 2025 | Fresenius Kabi USA, LLC Ivenix Infusion System (IIS), Large Volume Pump, Model Number: LVP-0004 Open, Classified |
FRN | K183311 |
| Dec 27, 2024 | Baxter Healthcare Corporation Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 8), Product Code 35700BAX2 Open, Classified |
FRN | K230022 |
| Dec 27, 2024 | Baxter Healthcare Corporation Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 6), Product Code 35700BAX Open, Classified |
FRN | K133801 |
| Nov 22, 2024 | Zyno Medical LLC Brand Name: Z-800 Infusion System
Product Name: Z-800WF
Model/Catalog Number: Z-800WF.
The Z-800 Infusion system is intended to provide intravenous infusion of parenteral fluids, blood, and blood prod Open, Classified |
FRN | K100705 K130690 |
| Nov 21, 2024 | Zyno Medical LLC Z-800 Infusion System. Model/Catalog Number: Z-800, Z-800F, Z-800W, Z-800WF.
The Z-800 Infusion system is intended to provide intravenous infusion of parenteral fluids, blood, and blood products to Open, Classified |
FRN | K100705 K130690 |
| Nov 21, 2024 | ICU Medical, Inc. Allegedly counterfeit batteries manufactured by CSB batteries being used with Plum Infusion Systems: Plum 360" Infusion System, Pump List Number 30010; Plum A+ & Plum A+3" Infusion Systems, Pump List Open, Classified |
FRN | None listed |
| Nov 8, 2024 | Baxter Healthcare Corporation Baxter Spectrum IQ Infusion System with Dose IQ Safety Software, Product Code 3570009 Open, Classified |
FRN | K230041 |
| Oct 31, 2024 | Smiths Medical ASD Inc. CADD-Solis Li-ion Rechargeable Battery Packs, REF 21-2160-XX, which are also sold as a component of the following CADD Solis Ambulatory Infusion Systems: 21-2101-0100-50, 21-2101-0200-02, 21-2101-020 Open, Classified |
FRN | K111275 |
| Oct 9, 2024 | Zyno Medical LLC Z-800 Infusion System, Model Numbers Z-800, Z-800F, Z-800W, Z-800WF;
Software Version: Z-800 6.1.01 and 6-1.07z; Z-800F 4.1.02 and 4.1.08z; Z-800W 3.1.32 and 3.1.64z, Z-800WF 3.1.32 and 3.1.64z Open, Classified |
FRN | K100705 K130690 |
| Sep 26, 2024 | Fresenius Kabi USA, LLC Ivenix Infusion System (IIS), LVP Software; LVP-SW-0004, Software Version 5.9.1 and prior. Infusion pump software for infusion management system. Open, Classified |
FRN | K183311 |
| Sep 13, 2024 | CareFusion 303, Inc. Alaris Pump Module Model 8100, a modular infusion pump and monitoring system Open, Classified |
FRN | K211218 |
| Sep 13, 2024 | CareFusion 303, Inc. Alaris Syringe Module Model 8110, a modular infusion pump and monitoring system Open, Classified |
FRN | K211218 |
| Sep 13, 2024 | CareFusion 303, Inc. Alaris EtCO2 Module Model 8300, a modular infusion pump and monitoring system Open, Classified |
FRN | K211218 |
| Sep 13, 2024 | CareFusion 303, Inc. Alaris PCA Module Model 8120, a modular infusion pump and monitoring system Open, Classified |
FRN | K211218 |
| Sep 13, 2024 | CareFusion 303, Inc. Alaris System PC Unit Model 8015 - a modular infusion pump and monitoring system Open, Classified |
FRN | K211218 |
| Sep 7, 2024 | B Braun Medical Inc Infusomat Space Infusion System/ Large Volume Pump, Product Code 8713050U Open, Classified |
FRN | K191910 |
| Aug 16, 2024 | Baxter Healthcare Corporation Spectrum Wireless Battery Modules A/B/G/N, product code 36010, used with either of the following 35700BAX2 (Spectrum V8 infusion pump) and 3570009 (Spectrum IQ infusion pump) Open, Classified |
FRN | K230041 |
| Aug 16, 2024 | Baxter Healthcare Corporation Baxter Spectrum Wireless Battery Modules A/B/G/N, product code 35223, used with either of the following: 35700BAX2 (Spectrum V8 infusion pump) or 3570009 (Spectrum IQ infusion pump) Baxter SIGMA Spec Open, Classified |
FRN | K230022 |
| Aug 9, 2024 | ICU Medical Inc Plum 360/A+ spare batteries. Item Number: SUB0000864. Open, Classified |
FRN | K042081 K070398 |
| Aug 9, 2024 | ICU Medical Inc Replacement Battery List Number SUB0000594 and SUB0000864 found in Plum A+ & Plum A+3 Infusion Systems, Pump List Numbers: 11005, 11971, 12391, 12618, 20678, 20679, 20792, 60529, 12348, 11973.
OUS un Open, Classified |
FRN | K042081 K070398 |
| Aug 9, 2024 | ICU Medical Inc Replacement Battery List Number SUB0000864, found in Plum 360 Infusion System, List Number 30010. Product description is PLUM 360 Infuser.
OUS units marketed with the following descriptions: Bomba de Open, Classified |
FRN | K141789 K161469 |
| Aug 7, 2024 | Baxter Healthcare Corporation Baxter SIGMA Spectrum Infusion Pump, Product Code: 35700BAX2 Open, Classified |
FRN | K230022 |
| Aug 3, 2024 | Smiths Medical ASD Inc. CADD-Solis VIP ambulatory Infusion Pumps, Model 2120 (21-2120, 21-2125, and 21-2127)
Indicated for the following uses:
Intra-arterial, subcutaneous, intraperitoneal, in close proximity to nerves, into Open, Classified |
FRN | K111275 |
| Jul 25, 2024 | B Braun Medical Inc Brand Name: Perfusor Space
Product Name: Perfusor Space Syringe Pump, Non-Wireless
Model/Catalog Number: 8713032U
Product Description: Perfusor Space Syringe Pump, Non-Wireless, Infusion Pump, 1 each
Open, Classified |
FRN | K172831 K191910 |
| Jul 25, 2024 | B Braun Medical Inc Brand Name: Perfusor Space
Product Name: PERFUSOR SPACE ACM-KIT
Model/Catalog Number: 8713040U
Product Description: Perfusor Space, Infusion Pump Kit, 1 each
Component: N/A Open, Classified |
FRN | K092313 |
| Jul 25, 2024 | B Braun Medical Inc Brand Name: Perfusor Space
Product Name: Perfusor PCA Syringe Pump
Model/Catalog Number: 8713080U
Product Description: Perfusor Space Syringe Pump, Infusion Pump, 1 each
Component: N/A Open, Classified |
FRN | K092313 K191910 |
| Jul 25, 2024 | B Braun Medical Inc Brand Name: Perfusor Space
Product Name: Perfusor Space Syringe Pump, Wireless
Model/Catalog Number: 8713031U
Software Version: 8713031U
Product Description: Perfusor Space Syringe Pump, Infusion Pump Open, Classified |
FRN | K172831 K191910 |
| Jul 25, 2024 | B Braun Medical Inc Brand Name: Perfusor Space
Product Name: Perfusor Space Infusion Pump System
Model/Catalog Number: 8713030U
Product Description: Perfusor Space Infusion Pump System, Infusion Pump, 1 each
Component: Open, Classified |
FRN | K092313 K172831 +1 |
| Jul 3, 2024 | Zyno Medical LLC Zyno Medical Z800, Z800F, Z800W, and Z800WF Infusion Pumps Open, Classified |
FRN | K130690 |
| Jul 3, 2024 | CareFusion 303, Inc. BD Alaris System Manager REF: 9601, compatible with BD Alaris PC Units Open, Classified |
FRN | K211218 |
| May 21, 2024 | OptumHealth Care Solutions LLC Optum Nimbus II Plus, Model number AAA-00170; Ambulatory Infusion Pump Open, Classified |
FRN | K153193 |
| May 13, 2024 | Baxter Healthcare Corporation Spectrum IQ Infusion pump, Product Code 357009 Open, Classified |
FRN | K230041 |
| May 3, 2024 | Baxter Healthcare Corporation Baxter Spectrum IQ Infusion Pump, Product Code 3570009 Open, Classified |
FRN | K230041 |
| Apr 15, 2024 | Smiths Medical ASD Inc. Smiths Medical Model 3010 Syringe pumps:
a. Protege Model 3010,
b. Medfusion Model 3010A,
c. Protege UK Model 3010E Open, Classified |
FRN | K040899 |
| Apr 15, 2024 | Smiths Medical ASD Inc. Smiths Medical Medfusion Model 4000 Syringe pump, Item Numbers:
a) 4000-0101-249,
b) 4000-0101-50,
c) 4000-0101-51,
d) 4000-0105-249,
e) 4000-0105-50,
f) 4000-0105-51,
g) 4000-0105-78,
h) 400 Open, Classified |
FRN | K111386 |
| Apr 15, 2024 | Smiths Medical ASD Inc. Smiths Medical Medfusion Model 3500 Syringe pumps, Item Numbers:
a) 3500
b) 3500-0600-00
c) 3500-0600-01
d) 3500-0600-249
e) 3500-0600-50
f) 3500-0600-51
g) 3500-0600-82
h) 3500-306
i) 3500-402
j) 3 Open, Classified |
FRN | K040899 |
| Apr 11, 2024 | Fresenius Kabi USA, LLC LVP Software of the Ivenix Infusion System (IIS), Version 5.8.0. Open, Classified |
FRN | K183311 |
| Mar 28, 2024 | InfuTronix LLC Nimbus II Infusion System;
Nimbus II PainPRO IT1053;
Nimbus II Flex IT1062;
Nimbus II Plus IT1078;
Nimbus II EpiD IT1124;
Nimbus II EMS IT1063;
Ambulatory Infusion Pump and components Open, Classified |
FRN | K140783 K153193 |
| Mar 28, 2024 | InfuTronix LLC Nimbus Administration Set;
Nimbus Flex;
Nimbus PainPro (a.k.a. Halo Ambulatory Infusion
System);
Catalog Number IT1025. Ambulatory Infusion Pump and components Open, Classified |
FRN | K140783 K153193 |
| Mar 11, 2024 | Fresenius Kabi USA, LLC LVP software of the Ivenix Infusion System (IIS); LVP-SW-0004 Completed |
FRN | K183311 |
| Mar 11, 2024 | Fresenius Kabi USA, LLC LVP software of the Ivenix Infusion System (IIS), LVP-SW-0004 Completed |
FRN | K183311 |
| Feb 23, 2024 | Zyno Medical LLC Zyno Medical Z800 Large Volume Infusion Pumps -Intended to provide intravenous infusion of parenteral fluids, blood and blood products to a patient under the direction or supervision of physician or o Open, Classified |
FRN | K130690 |
| Feb 1, 2024 | Smiths Medical ASD Inc. smiths medical Medfusion Model 4000 syringe pump Open, Classified |
FRN | K111386 |
| Feb 1, 2024 | Smiths Medical ASD Inc. smiths medical Medfusion Model 3500 Syringe pump Open, Classified |
FRN | K040899 |
| Dec 20, 2023 | Fresenius Kabi USA, LLC Ivenix Infusion System (IIS), Large Volume Pump LVP-0004 Open, Classified |
FRN | K183311 |
| Nov 9, 2023 | Baxter Healthcare Corporation Novum IQ Syringe infusion system, Product Code 40800BAXUS Open, Classified |
FRN | K211125 |
| Nov 7, 2023 | CareFusion 303, Inc. Alaris PCA Module 8120 Open, Classified |
FRN | K051641 K072105 +2 |
Free CSV: newest 100 rows. Paid plans export up to 1,000 or 10,000 rows.