510(k) K133801 ยท FRN Pump, Infusion
BAXTER SIGMA SPECTRUM INFUSION PUMP WITH MASTER DRUG LIBRARY
| Applicant | Baxter Healthcare Corporation, Round Lake IL, US |
| Decision | Substantially Equivalent, May 7, 2014 |
| Received | Dec 13, 2013 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K133801
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 17, 2025 | Baxter Healthcare Corporation Baxter SIGMA Spectrum Infusion Pump V6, Model Number 35700BAX Open, Classified |
PHC | None listed |
| Mar 6, 2025 | Baxter Healthcare Corporation Baxter Sigma Spectrum Infusion System (V6 Platform), Product Code 35700BAX Open, Classified |
FRN | None listed |
| Dec 27, 2024 | Baxter Healthcare Corporation Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 6), Product Code 35700BAX Open, Classified |
FRN | None listed |
| Jan 29, 2022 | Baxter Healthcare Corporation Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 8), Product code 35700BAX2. Open, Classified |
FRN | None listed |
| 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 8) - 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 8) Terminated |
FRN | None listed |
| Oct 22, 2020 | Baxter Healthcare Corporation Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 8) Terminated |
FRN | None listed |
| Jun 21, 2018 | Baxter Healthcare Corporation Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 6), product code 35700BAX - Product Usage: The Baxter SIGMA Spectrum Infusion Pump with Master Drug Library is intended to be used Terminated |
FRN | None listed |
| May 8, 2018 | Baxter Healthcare Corporation Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 8), infusion pump, 35700BAX2
Product Usage:
The Baxter SIGMA Spectrum Infusion Pump with Master Drug Library is intended to be us Terminated |
FRN | None listed |
| Oct 6, 2017 | Baxter Healthcare Corporation Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 6) (GTIN 00085412091570); Model Numbers: 35700BAX and 35700ABB.
Intended to be used for the controlled administration of fluids. Terminated |
FRN | None listed |
| Jan 26, 2017 | Baxter Healthcare Corporation Baxter SIGMA Spectrum Infusion Pump with Master Drug Library, Model #/Product Code 35700BAX2 Terminated |
FRN | None listed |
| Sep 28, 2016 | Baxter Healthcare Corp. Baxter SIGMA Spectrum INFUSION PUMP with Master Drug Library, V8 Spectrum Infusion Pump, Product Code 35700BAX2, Unique Device Identifier GTIN 00085412091570, Rx ONLY -- Baxter Healthcare Corporatio Terminated |
FRN | None listed |
| Sep 28, 2016 | Baxter Healthcare Corp. V6 Rear Case Assembly, Product Code 35701, a replacement part for the SIGMA Spectrum Infusion Pump -- SIGMA LLC Medina, NY 14103 --- NOTE: The speakers are a part of the rear case assembly located in Terminated |
FRN | None listed |
| Apr 16, 2015 | Baxter Healthcare Corp Master Drug Library Software version 8.0, Product Code 35723V080, to be used with SIGMA Spectrum Infusion System (Pump) version 8.0, Product Code 35700BAX2
The SIGMA Spectrum Infusion Pump with Mas Terminated |
FRN | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.