510(k) K042121 ยท FRN Pump, Infusion
SPECTRUM AND SPECTRUM WITH MASTER DRUG LIBRARY
| Applicant | Sigma Intl., Medina NY, US |
| Decision | Substantially Equivalent, Aug 26, 2004 |
| Received | Aug 6, 2004 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K042121
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 6, 2021 | Baxter Healthcare Corporation Infusion Pump Terminated |
FRN | None listed |
| 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 | None listed |
| 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 | None listed |
| Oct 22, 2020 | Baxter Healthcare Corporation Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 6) Terminated |
FRN | None listed |
| May 8, 2018 | Baxter Healthcare Corporation Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 6), infusion pump, 35700BAX and 35700ABB
Product Usage:
The Baxter SIGMA Spectrum Infusion Pump with Master Drug Library is inten Terminated |
FRN | None listed |
| May 4, 2018 | Baxter Healthcare Corporation Baxter Sigma Spectrum Infusion Pump with master Drug Library (Version 6) 35700BAX
Product Usage:
The Baxter Sigma Spectrum Infusion Pump with master Drug Library is intended to be used for the contro Terminated |
FRN | None listed |
| May 4, 2018 | Baxter Healthcare Corporation Baxter Sigma Spectrum Infusion Pump with master Drug Library (Version 6) 35700BAXL
Product Usage:
The Baxter Sigma Spectrum Infusion Pump with master Drug Library is intended to be used for the contr Terminated |
FRN | None listed |
| May 4, 2018 | Baxter Healthcare Corporation Baxter Sigma Spectrum Infusion Pump with Master Drug Library (Version 6) 35700BAXR
Product Usage:
The Baxter Sigma Spectrum Infusion Pump with master Drug Library is intended to be used for the contr Terminated |
FRN | None listed |
| May 4, 2018 | Baxter Healthcare Corporation Baxter Sigma Spectrum Infusion Pump with Master Drug Library (Version 6) 35700BAXRP
Product Usage:
The Baxter Sigma Spectrum Infusion Pump with master Drug Library is intended to be used for the cont Terminated |
FRN | None listed |
| May 4, 2018 | Baxter Healthcare Corporation Baxter Sigma Spectrum Infusion Pump with Master Drug Library (Version 6) 35700BAXRE
Product Usage:
The Baxter Sigma Spectrum Infusion Pump with master Drug Library is intended to be used for the cont Terminated |
FRN | None listed |
| Sep 28, 2016 | Baxter Healthcare Corp. sigma spectrum VOLUMETRIC INFUSION PUMP with Master Drug Library, V6 Spectrum Infusion Pump, Product Code 35700BAX and 35700BAXR, Unique Device Identifier GTIN 00085412091570, Rx ONLY -- Sigma, LLC Me Terminated |
FRN | None listed |
| Oct 1, 2014 | Baxter Healthcare Corp. SPECTRUM Pump, Model No. 35700BAX.
Intended to be used for the controlled administration of intravenous fluids. Terminated |
FRN | None listed |
| Apr 25, 2014 | Baxter Healthcare Corp. SIGMA SPECTRUM Volumetric Infusion Pump with Master Drug Library
Product Usage: Sigma Spectrum Volumetric Infusion Pumps with Master Drug Library are intended to be used for the controlled administr Terminated |
FRN | None listed |
| Nov 8, 2013 | Baxter Healthcare Corp. SIGMA SPECTRUM Infusion Pump with Master Drug Library.
Intended to be used for the controlled administration of intravenous fluids. Terminated |
FRN | None listed |
| Nov 8, 2013 | Baxter Healthcare Corp. SIGMA SPECTRUM Infusion Pump with Master Drug Library component (SHARP LCD screen, 55074-2 revision B)
Product Usage: Intended to be used as a visual aid during the controlled administration of intr Terminated |
FRN | None listed |
| Jul 18, 2012 | Sigma SIGMASpectrum Infusion Pump Master Drug Library (MDL) Editor software.
Product Usage:
A customized in-house library of all IV and epidural drugs, along with their safe delivery parameters. Terminated |
FRN | None listed |
| Jun 13, 2012 | Baxter Healthcare Corporation Sigma Spectrum VOLUMETRIC INFUSION PUMP, with or without Master Drug Library, Part Number 35700 -- Common/Classification Name: Infusion Pump -- Class 2 medical device -- SIGMA LLC, Medina, NY 14103
Terminated |
FRN | None listed |
| Nov 5, 2010 | Sigma International General Medical Apparatus, Llc Sigma Spectrum VOLUMETRIC INFUSION PUMP, with or without Master Drug Library, Part Number 35700 --
Common/Classification Name: Infusion Pump --Class 2 medical device -- SIGMA LLC, Medina, NY 14103 - Terminated |
FRN | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.