510(k) K230022 ยท FRN Pump, Infusion
Baxter SIGMA Spectrum Infusion Pump with Master Drug Library
| Applicant | Baxter Healthcare Corporation, Round Lake IL, US |
| Decision | Substantially Equivalent, Mar 31, 2023 |
| Received | Jan 4, 2023 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K230022
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 17, 2025 | Baxter Healthcare Corporation Baxter SIGMA Spectrum Infusion Pump V8, Model Number 35700BAX2 Open, Classified |
PHC | None listed |
| Dec 27, 2024 | Baxter Healthcare Corporation Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 8), Product Code 35700BAX2 Open, Classified |
FRN | None listed |
| Aug 16, 2024 | Baxter Healthcare Corporation Baxter Spectrum Wireless Battery Modules A/B/G/N, product code 35223, used with either of the following: 35700BAX2 (Spectrum V8 infusion pump) or 3570009 (Spectrum IQ infusion pump) Baxter SIGMA Spec Open, Classified |
FRN | None listed |
| Aug 7, 2024 | Baxter Healthcare Corporation Baxter SIGMA Spectrum Infusion Pump, Product Code: 35700BAX2 Open, Classified |
FRN | None listed |
| Jul 13, 2023 | Baxter Healthcare Corporation SIGMA Spectrum Infusion Pump, Product Code 35700BAX2 Open, Classified |
FRN | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.