BAXTER SIGMA SPECTRUM INFUSION PUMP WITH MASTER DRUG LIBRARY— 510(k) K133801
Substantially EquivalentBaxter Healthcare Corporation
FDA 510(k) clearance K133801 for BAXTER SIGMA SPECTRUM INFUSION PUMP WITH MASTER DRUG LIBRARY, Substantially Equivalent on 2014-05-07. Applicant: Baxter Healthcare Corporation. Device class: 2.
Clearance details
- Applicant
- Baxter Healthcare Corporation
- Product code
- Code FRN
- Device class
- Class 2
- Regulation
- 21 CFR 880.5725
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Round Lake, IL, US
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More clearances from Baxter Healthcare Corporation
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- K243529 — Solution Administration Sets
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Adverse events under product code FRN
product code FRN- Death
- 540
- Injury
- 6,178
- Malfunction
- 1,464,165
- Other
- 52
- Total
- 1,470,935
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recalls naming K133801
K-number listed on FDA's recall record- Z-2095-2025 — Baxter SIGMA Spectrum Infusion Pump V6, Model Number 35700BAX
- Z-1253-2025 — Baxter Sigma Spectrum Infusion System (V6 Platform), Product Code 35700BAX
- Z-0775-2025 — Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 6), Product Code 35700BAX
- Z-0530-2022 — Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 8), Product code 35700BAX2.
- Z-1150-2021 — Infusion Pump
- Z-0714-2021 — Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 8) - Product Usage: intended to be used for the controlled administration of fluids.
- Z-0121-2021 — Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 8)
- Z-0122-2021 — Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 8)
- Z-1248-2019 — 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 for the controlled administration of fluids. These fluids may include pharmaceutical drugs, blood, blood products and mixture of required patient therapy. The intended routes of administration consist of the following clinically accepted routes: intravenous, arterial, subcutaneous, intrathecal, epidural or irrigation of fluid space. Spectrum Infusion Pump is intended to be used in conjunction with legally marketed intravenous administration sets and medications provided by the user. The Spectrum and Spectrum with Master Drug Library is suitable for many user facility applications such as but not limited to hospitals, outpatient care areas, homecare and ambulatory care services. Spectrum and Spectrum with Master Drug Library is intended to reduce operator interaction through automated programming thereby helping to reduce errors associated with complex device programming. Parameter programming requires trained healthcare professional confirmation of limits and drug therapy to the physician s directive.
- Z-2113-2018 — 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 used for the controlled administration of fluids. These fluids may include pharmaceutical drugs, blood, blood products and mixture of required patient therapy. The intended routes of administration consist of the following clinically accepted routes: intravenous, arterial, subcutaneous, intrathecal, epidural or irrigation of fluid space. Spectrum Infusion Pump is intended to be used in conjunction with legally marketed intravenous administration sets and medications provided by the user. The Spectrum and Spectrum with Master Drug Library is suitable for many user facility applications such as but not limited to hospitals, outpatient care areas, homecare and ambulatory care services. Spectrum and Spectrum with Master Drug Library is intended to reduce operator interaction through automated programming thereby helping to reduce errors associated with complex device programming. Parameter programming requires trained healthcare professional confirmation of limits and drug therapy to the physicians directive.
- Z-0971-2018 — 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.
- Z-1693-2017 — Baxter SIGMA Spectrum Infusion Pump with Master Drug Library, Model #/Product Code 35700BAX2
- Z-0671-2017 — 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 Corporation, Medina, NY 14103 --- NOTE: The speakers are a part of the rear case assembly located in the back of the infusion pump. The speaker is intended to generate audible tones during each keystroke, and during alarm conditions. However, some speakers have a variation in their internal wiring that increases the potential for the speaker to fail prematurely. Spectrum Infusion Pumps with non-functional speakers will continue to display visual alarm indications, and will otherwise continue to operate as intended.
- Z-0672-2017 — 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 the back of the infusion pump. The speaker is intended to generate audible tones during each keystroke, and during alarm conditions. However, some speakers have a variation in their internal wiring that increases the potential for the speaker to fail prematurely. Spectrum Infusion Pumps with non-functional speakers will continue to display visual alarm indications, and will otherwise continue to operate as intended. Product Code 35701 is a replacement assembly that is shipped to customers for self-repair of the Spectrum Infusion Pump. It is not a registered finished good.
- Z-1451-2015 — 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 Master Drug Library (MDL) is intended to be used for the controlled administration of fluids.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K133801.
Data sourced from openFDA. This site is unofficial and independent of the FDA.