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) |
|---|---|---|---|
| Nov 23, 2020 | Baxter Healthcare Corporation Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 6) - Product Usage: intended to be used for the controlled administration of fluids. Open, Classified |
FRN | K042121 |
| Nov 23, 2020 | Baxter Healthcare Corporation Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 6) - Product Usage: intended to be used for the controlled administration of fluids. Open, Classified |
FRN | K042121 |
| Oct 22, 2020 | Baxter Healthcare Corporation Spectrum IQ Infusion System with Dose IQ Safety Software Terminated |
FRN | K173084 |
| Oct 22, 2020 | Baxter Healthcare Corporation Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 8) Terminated |
FRN | K133801 |
| Oct 22, 2020 | Baxter Healthcare Corporation Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 8) Terminated |
FRN | K133801 |
| Oct 22, 2020 | Baxter Healthcare Corporation Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 6) Terminated |
FRN | K042121 |
| Sep 4, 2020 | CareFusion 303, Inc. PC Unit Front Case with Keypad Replacement Kits:
TC10008389 ASSY CASE FRONT W/KEYPAD 8015LS,
TC10010217 ASSY FRT CASE W/ KEYPAD 8015 M2,
TC10012515 ASSY FR CASE W/ KEYPAD 8015 M2,
TC10013702 ASSY, CAS Open, Classified |
FRN | K133532 |
| Sep 4, 2020 | CareFusion 303, Inc. BD Alaris System; Alaris Syringe Module Model 8110;
BD Alaris System; Alaris PCA Module Model 8120;
BD Alaris System; Syringe/PCA Sizer Sensor Replacement Kit, P/N 122278652 Open, Classified |
FRN | K043299 K133532 |
| Sep 4, 2020 | CareFusion 303, Inc. Alaris System PC Unit Model 8015 Open, Classified |
FRN | K133532 |
| Aug 19, 2020 | CareFusion 303, Inc. Alaris SpO2 Module Model 8210 and Model 8220 - Product Usage: is intended to provide trained healthcare caregivers a way to automate the programming of infusion parameters, thereby decreasing the amou Open, Classified |
FRN | K133532 |
| Aug 19, 2020 | CareFusion 303, Inc. Alaris EtCO2 Module Model 8300 - Product Usage: is intended to provide trained healthcare caregivers a way to automate the programming of infusion parameters, thereby decreasing the amount of manual s Open, Classified |
FRN | K133532 |
| Aug 19, 2020 | CareFusion 303, Inc. Alaris PCA Module Model 8120 - Product Usage: is intended to provide trained healthcare caregivers a way to automate the programming of infusion parameters, thereby decreasing the amount of manual ste Open, Classified |
FRN | K133532 |
| Aug 19, 2020 | CareFusion 303, Inc. Alaris Syringe Module Model 8110 - Product Usage: is intended to provide trained healthcare caregivers a way to automate the programming of infusion parameters, thereby decreasing the amount of manual Open, Classified |
FRN | K133532 |
| Aug 19, 2020 | CareFusion 303, Inc. Alaris Pump Module Model 8100 - Product Usage: is intended to provide trained healthcare caregivers a way to automate the programming of infusion parameters, thereby decreasing the amount of manual st Open, Classified |
FRN | K133532 |
| Aug 6, 2020 | CareFusion 303, Inc. Alaris Pump Module Model 8100 Terminated |
FRN | K133532 |
| Aug 6, 2020 | CareFusion 303, Inc. Alaris System PC Unit Model 8015. modular infusion pump and monitoring system Terminated |
FRN | K133532 |
| Aug 6, 2020 | CareFusion 303, Inc. Alaris System PC Unit Model 8000 modular infusion pump and monitoring system Terminated |
FRN | K133532 |
| Aug 6, 2020 | Smiths Medical ASD Inc. Medfusion Syringe Pump Model 3500, Software Version V6.0. Infusion pump. Open, Classified |
FRN | K040899 K111386 |
| Aug 6, 2020 | Smiths Medical ASD Inc. Medfusion Syringe Pump Model 4000; Software Versions V1.5.0, V1.5.1, V1.6.0, and V1.6.1 Open, Classified |
FRN | K040899 K111386 |
| Aug 6, 2020 | CareFusion 303, Inc. Alaris Auto ID Module Model 8600, a modular infusion pump and monitoring system Terminated |
FRN | K133532 |
| Aug 6, 2020 | CareFusion 303, Inc. Alaris SpO2 Module Model 8210 and Model 8220, a modular infusion pump and monitoring system Terminated |
FRN | K133532 |
| Aug 6, 2020 | CareFusion 303, Inc. Alaris EtCO2 Module Model 8300, a modular infusion pump and monitoring system Terminated |
FRN | K133532 |
| Aug 6, 2020 | CareFusion 303, Inc. Alaris PCA Module Model 8120, a modular infusion pump and monitoring system Terminated |
FRN | K133532 |
| Aug 6, 2020 | CareFusion 303, Inc. Alaris Syringe Module Model 8110, a modular infusion pump and monitoring system Terminated |
FRN | K133532 |
| Aug 6, 2020 | CareFusion 303, Inc. Alaris Pump Module Model 8100, a modular infusion pump and monitoring system Terminated |
FRN | K133532 |
| Aug 6, 2020 | CareFusion 303, Inc. Alaris System PC Unit Model 8015, a modular infusion pump and monitoring system Terminated |
FRN | K133532 |
| Aug 6, 2020 | CareFusion 303, Inc. Alaris System PC Unit Model 8000, a modular infusion pump and monitoring system Terminated |
FRN | K133532 |
| Aug 4, 2020 | CareFusion 303, Inc. BD Alaris System PC Unit Model 8100 (Pump Module) and Pump Module Door Assembly Replacement Kits (P/N 49000239, 49000346, 49000438, 49000439) infusion pump. Open, Classified |
FRN | K133532 |
| Jul 30, 2020 | CME America, LLC CME America T-Syringe Pump - T34 - Product Usage: infusion of medications or fluids requiring continuous or intermittent delivery at precisely-controlled infusion rates through clinically acceptable r Terminated |
FRN | K080954 |
| Jul 30, 2020 | CME America, LLC CME America T-Syringe Pump - Ameritus 1st Enteral Pump - Product Usage: infusion of medications or fluids requiring continuous or intermittent delivery at precisely-controlled infusion rates through c Terminated |
FRN | K080954 |
| Jul 30, 2020 | CME America, LLC CME America T-Syringe Pump - Neofeed - Product Usage: infusion of medications or fluids requiring continuous or intermittent delivery at precisely-controlled infusion rates through clinically acceptab Terminated |
FRN | K080954 |
| Jul 30, 2020 | CME America, LLC CME America T-Syringe Pump - T34L PCA - Product Usage: infusion of medications or fluids requiring continuous or intermittent delivery at precisely-controlled infusion rates through clinically accepta Terminated |
FRN | K080954 |
| Jul 30, 2020 | CME America, LLC CME America T-Syringe Pump - NeoThrive - Product Usage: infusion of medications or fluids requiring continuous or intermittent delivery at precisely-controlled infusion rates through clinically accept Terminated |
FRN | K080954 |
| Jul 30, 2020 | CME America, LLC CME America T-Syringe Pump -T34L - Product Usage: infusion of medications or fluids requiring continuous or intermittent delivery at precisely-controlled infusion rates through clinically acceptable r Terminated |
FRN | K080954 |
| Mar 18, 2020 | CME America, LLC CME America BodyGuard Infusion Pump System, All models of BG 323, BG 121, BG 545, BG CV545, BG 575, BG CV575, and CMExpress Terminated |
FRN | K061325 |
| Mar 11, 2020 | CME America, LLC BodyGuard Microset REF A120-003XYVA, Sterile EO, Tubing: 150 in. (380 cm), Prime Vol: approx. 8ml
Product Usage: The BodyGuard Infusion Pump System is designed to transfer medication and fluids int Terminated |
FRN | K042696 |
| Mar 5, 2020 | CareFusion 303, Inc. CareFusion Alaris PCA Module, Model 8120 Open, Classified |
FRN | K012383 K051641 |
| Mar 5, 2020 | CareFusion 303, Inc. CareFusion Alaris Syringe Module, Model 8110 Open, Classified |
FRN | K012383 K051641 |
| Mar 5, 2020 | CareFusion 303, Inc. CareFusion Alaris Pump Module, Model 8100 Open, Classified |
FRN | K012383 K051641 |
| Mar 5, 2020 | CareFusion 303, Inc. CareFusion Alaris System, Alaris PC unit models 8000 and 8015 (UDI: 10885403801518) Open, Classified |
FRN | K133532 |
| Feb 27, 2020 | CME America LLC CMEAmerica BodyGuard Wall Charger: Lot number 2019-0364, Mode/Catalogue number 151-143XL, *+B 01151143X L0/$$72019-0364/ 16D20191101/*
Lot Number Label: BODYGUARD LOT 2019-0364 Manufacturing Date: 20 Terminated |
FRN | K042696 |
| Dec 12, 2019 | Smiths Medical ASD Inc. Medfusion Syringe Pump, Model 4000. The Model 4000 pump is a small, lightweight and portable syringe infusion pump. The pump offers a variety of delivery modes programmable to meet specific patient Terminated |
FRN | K111386 |
| Oct 22, 2019 | ICU Medical Inc Plum 360 Infusion System With MedNet/ Smart Card Plug And Play Module, Model # 30010. Infusion pump. Terminated |
FRN | K161469 |
| Aug 12, 2019 | Fenwal Inc VOLUMAT MC AGILIA US, Infusion Pump, REF Z021135, software versions 1.7 and 1.9a
Product Usage:
The Volumat MC Agilia is a piece of transportable medical equipment intended to be used in healthcare f Terminated |
FRN | K121613 |
| Jul 29, 2019 | ICU Medical Inc Infusion Pump I.V. Administration, specifically Sapphire Microbore Infusion Sets with Inline Filters labeled as SAPPHIRE Epidural Set Yellow-Striped Microbore, 0.2 Micron Filter 301 cm / 8.3 mL. 1 un Terminated |
FRN | None listed |
| Jul 29, 2019 | ICU Medical Inc Infusion Pump I.V. Administration, specifically Sapphire Microbore Infusion Sets with Inline Filters labeled as SAPPHIRE Epidural Set Yellow-Striped Microbore, 0.2 Micron Filter 301 cm / 8.3 mL. 1 un Terminated |
FRN | None listed |
| Jul 29, 2019 | ICU Medical Inc Infusion Pump I.V. Administration, specifically Sapphire Microbore Infusion Sets with Inline Filters labeled as SAPPHIRE Primary 0.2 Micron Filter Set Non-Vented, Microbore, 293 cm / 8.1 mL. 1 unit p Terminated |
FRN | None listed |
| Jul 29, 2019 | ICU Medical Inc Infusion Pump I.V. Administration, specifically Sapphire Microbore Infusion Sets with Inline Filters labeled as SAPPHIRE Primary 1.2 Micron Filter Set Non-Vented, Microbore 311 cm / 8.4 mL. 1 unit pe Terminated |
FRN | None listed |
| Jul 29, 2019 | ICU Medical Inc Infusion Pump I.V. Administration, specifically Sapphire Microbore Infusion Sets with Inline Filters labeled as SAPPHIRE Primary 1.2 Micron Filter Set Non-Vented, Microbore 311 cm / 8.4 mL. 1 unit pe Terminated |
FRN | None listed |
| Jul 29, 2019 | ICU Medical Inc Infusion Pump I.V. Administration, specifically Plum Microbore Infusion Sets with Inline Filters labeled as Primary PLUM Set, 15 Micron Filter in Sight Chamber, CLAVE Secondary Port, 0.2 Micron Filter Terminated |
FRN | None listed |
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