Panels › General Hospital › Product code NEP · Class 2
System/Device, Pharmacy Compounding
Regulation 880.5440
0510(k)s in 12 months (0 all time)
2recalls in 12 months (42 all time)
8recalls that name a 510(k)
Top companies in NEP
| Company | 510(k)s | Recalls |
|---|---|---|
| Baxter Healthcare Corp. | 0 | 9 |
| The Metrix Company | 0 | 8 |
| Baxa Corporation | 0 | 7 |
| ICU Medical, Inc. | 0 | 6 |
| B Braun Medical, Inc. | 0 | 4 |
| Baxter Corporation Englewood | 0 | 3 |
| OmniCell, Inc. | 0 | 2 |
| Smiths Medical ASD Inc. | 0 | 2 |
| HEALTH ROBOTICS S.R.L. | 0 | 1 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 29, 2026 | Baxter Healthcare Corporation Brand Name: Exacta Mix
Product Name: Vented Micro-Volume Inlet
Model/Catalog Number: H938175
Product Description: Tubing sets with push-on connector on one end (to attach to the Fluid Selector Valve Open, Classified |
NEP | K002705 |
| May 13, 2026 | Omnicell, Inc. Rolls of label stock used with the Omnicell i.v.Station.
1. Part Number 258920028, LABEL, STERILE, IVSTATION SYRINGE (40MMX40MM).
2. Part Number 258900029, LABEL, STERILE, IVSTATION SYRINGE (20M Open, Classified |
NEP | None listed |
| May 22, 2023 | OmniCell, Inc. Omnicell IVX Station-For use in the automated preparation of pharmaceutical admixtures and syringes
Model Number: 298921373 Open, Classified |
NEP | None listed |
| Jul 22, 2022 | Baxter Healthcare Corporation ABACUS TPN (Total Parenteral Nutrition) Calculation software, Product codes: 8300-0167 (Abacus V3.1 CE), 8300-0168 (Abacus V3.1 SE), 8300-0169 (Abacus V3.1 ME), 8300-0191 (Abacus V3.2 CE), 8300-0192 Terminated |
NEP | None listed |
| Apr 21, 2021 | Smiths Medical ASD Inc. ANGIOGRAPHIC KIT W/MX123-3MR MANIFOLD, Model Number MX1030. for use during angiography and other special procedures. Terminated |
NEP | None listed |
| Apr 21, 2021 | Smiths Medical ASD Inc. Left Heart Kit, Model Number M20268. for blood pressure monitoring. Terminated |
NEP | None listed |
| Nov 23, 2020 | B Braun Medical, Inc. APEX Compounding System Control Panel Module, REF: 601238, Product Code AX1000 - Product Usage: intended for intravascular administration to a patient. Terminated |
NEP | None listed |
| Nov 23, 2020 | B Braun Medical, Inc. APEX Compounding System Control Panel Module, REF: 601237, Product Code AX1000 - Product Usage: intended for intravascular administration to a patient. Terminated |
NEP | None listed |
| Nov 23, 2020 | B Braun Medical, Inc. APEX Compounding System Control Panel Module, REF: 601224, Product Code AX1000 - Product Usage: intended for intravascular administration to a patient. Terminated |
NEP | None listed |
| Jun 4, 2018 | B. Braun Medical, Inc. 26-Lead Transfer Set for use with APEX Compounding System, Product Catalog Number 2112550 Terminated |
NEP | K151423 |
| Jan 10, 2017 | HEALTH ROBOTICS S.R.L. i.v. Station and i.v. Station ONCO Automated Drug Compounding System, Pharmacy Compounding System
Device Listing Number E454448 Terminated |
NEP | None listed |
| Jun 23, 2016 | The Metrix Company Container fill and transfer sets, 250 mL and 500 mL, .
. Terminated |
NEP | None listed |
| Jun 23, 2016 | The Metrix Company Dual Chamber Container fill with gravity/attached transfer sets, 250 mL / 1250 mL, 300 mL / 1700 mL, 500 mL / 2500 mL, 500 mL / 3500 mL Terminated |
NEP | K960581 |
| Jun 23, 2016 | The Metrix Company Dual Chamber Container fill and transfer sets, 250 mL / 1250 mL or 500 mL / 2500 mL Terminated |
NEP | K926123 |
| Jun 23, 2016 | The Metrix Company Container fill and transfer sets, automatic fill compatible, 250 mL, 500 mL, 1000 mL, 1500 mL, 2000 mL, 3000 mL, or 4000 mL. Terminated |
NEP | K843523 |
| Jun 23, 2016 | The Metrix Company Container fill and transfer sets, 250 mL, 500 mL, 1000 mL, 2000 mL, 3000 mL, or 4000 mL. Terminated |
NEP | K030888 |
| Jun 23, 2016 | The Metrix Company AUTOCOMP6 High Speed Compounder Terminated |
NEP | None listed |
| Jun 23, 2016 | The Metrix Company AUTOCOMP6 XP High Speed Compounder REF 58810 Terminated |
NEP | None listed |
| Jun 23, 2016 | The Metrix Company AUTOCOMP6 XPS High Speed Compounder REF 58810 Terminated |
NEP | None listed |
| Mar 8, 2016 | ICU Medical, Inc. Diana Automated Compounding System, Diana V1.3, Item No. CH5300, CH5300R
The Diana is an automated compounding device for the accurate, safe and efficient preparation of solutions by a pharmacist prio Terminated |
NEP | None listed |
| Mar 8, 2016 | ICU Medical, Inc. Diana Automated Compounding System, Final Assembly, Diana Onco Plus, Item No. CH5000, CH5000R
The Diana is an automated compounding device for the accurate, safe and efficient preparation of solutions Terminated |
NEP | None listed |
| Mar 8, 2016 | ICU Medical, Inc. Diana Automated Compounding System, Diana Onco 3xx, Item No. ASN303
The Diana is an automated compounding device for the accurate, safe and efficient preparation of solutions by a pharmacist prior to Terminated |
NEP | None listed |
| Mar 8, 2016 | ICU Medical, Inc. Diana Automated Compounding System, Diana Onco Plus 1.3, Item No. ASN223
The Diana is an automated compounding device for the accurate, safe and efficient preparation of solutions by a pharmacist prio Terminated |
NEP | None listed |
| Mar 8, 2016 | ICU Medical, Inc. Diana Automated Compounding System, Diana Onco Plus 1.2, Item No. ASN222, ASN222-GST, ASN222-R
The Diana is an automated compounding device for the accurate, safe and efficient preparation of solution Terminated |
NEP | None listed |
| Mar 8, 2016 | ICU Medical, Inc. Diana Automated Compounding System, Diana Onco Plus, Item No. ASN220
The Diana is an automated compounding device for the accurate, safe and efficient preparation of solutions by a pharmacist prior to Terminated |
NEP | None listed |
| Nov 30, 2015 | Baxter Healthcare Corp. Baxter CLEARLINK System, Blood Bag Spike Adapter, Luer Activated Valve for I.C. Access, 1C8687,
Product Usage:
C8687: An accessory to transfer a medicinal product from one container to another conta Terminated |
NEP | None listed |
| May 18, 2015 | Baxter Corporation Englewood ABACUS SE (Single-Workstation Edition) and ABACUS ME (Multi-Workstation Edition)
Product Usage:
The ABACUS Software is a Windows-based order entry software application for comprehensive total parente Terminated |
NEP | None listed |
| Jun 22, 2014 | Baxter Corporation Englewood Abacus 3.1, Pharmacy Calculator
Product Usage:
Provide pharmacy calculations for automated compounding. Terminated |
NEP | None listed |
| May 12, 2014 | Baxter Corporation Englewood ABACUS TPN Calculation Software, Product Codes: 8300-0045 ABACUS CE (Calculator Edition), 8300-0046 ABACUS SE (Single-Workstation Edition), 8300-0047 ABACUS ME (Multi-Workstation Edition), 8300-0156 A Terminated |
NEP | None listed |
| Dec 29, 2013 | Baxter Healthcare Corp. IntelliFill i.v. Pharmacy Compounding Device (PCD).
Intended to fill syringes from 0.5mL up to 11.5mL using mixing instructions from its formulary to fill the orders. Terminated |
NEP | None listed |
| Oct 25, 2012 | Baxa Corporation Repeater Pump, Class II device used for facilitating repeatable drug dosage distribution and reconstitution in hospital pharmacies. The device are Fluid Transfer Tube Sets, Sterile/EO, Std Volume Tri Terminated |
NEP | None listed |
| Aug 8, 2012 | Baxter Healthcare Corp. AUTOMIX 3+3 Compounder with Accusource Monitoring System, product 2M8287; automated nutrition compounders;
Product Usage: The Automix Compounder Systems are electromechanical positive displacement Terminated |
NEP | None listed |
| Aug 8, 2012 | Baxter Healthcare Corp. AUTOMIX 3+3 Compounder System, product 2M8286 (115V) and 2M8286K (230V), automated nutrition compounders;
Product Usage: The Automix Compounder Systems are electromechanical positive displacement f Terminated |
NEP | None listed |
| Aug 8, 2012 | Baxter Healthcare Corp. AUTOMIX Plus High Speed Compounder System, product 2M8075; automated nutrition compounders;
Product Usage: The Automix Compounder Systems are electromechanical positive displacement fluid compoundi Terminated |
NEP | None listed |
| Aug 8, 2012 | Baxter Healthcare Corp. AUTOMIX High Speed Compounder System, product 2M8077; automated nutrition compounders;
Product Usage: The Automix Compounder Systems are electromechanical positive displacement fluid compounding de Terminated |
NEP | None listed |
| Apr 9, 2012 | Baxa Corporation Pharmacy compounding system . It is a twenty-four source compounder for multi-source fluid mixing of both macro and micro ingredient down to 0.2 ml quantities.
Product Usage: Pharmacy compounding Sy Terminated |
NEP | None listed |
| Apr 5, 2012 | Baxa Corporation The EM 2400 is a Pharmacy Compounding System consisting of three sub-systems for compounding solutions for intravascular administration.
Pharmacy compounding system for mixing ingredients for intrava Terminated |
NEP | None listed |
| Aug 19, 2008 | Baxa Corporation Exacta-Mix 600 Pharmacy Compounding System is used in the pharmacy to compound multiple source ingredients into on final solution based on user-specified sequences and volumes. Terminated |
NEP | None listed |
| Aug 19, 2008 | Baxa Corporation Exacta-Mix 2400, Pharmacy Compounding System is used in the pharmacy to compound multiple source ingredients into on final solution based on user-specified sequences and volumes. Terminated |
NEP | None listed |
| Sep 27, 2007 | Baxa Corporation Exacta-Mix 2400, OS v1.07, Model No. 8300-0073, Pharmacy Compounding System, Baxa Corporation, Englewood, CO 80112. Terminated |
NEP | None listed |
| Jul 20, 2004 | Baxter Healthcare Corp. Clintec Micromix Compounder, an I.V. solution compounder; Baxter Healthcare Corporation, Clintec Nutrition Division, Deerfield, IL 60015 USA; product code 2M8290 - 1.0 mL accuracy, and product code 2M Terminated |
NEP | K955622 |
| Jul 20, 2004 | Baxa Corporation Exacta-Mix 2400 pharmacy compounding system. Terminated |
NEP | K002705 |
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