510(k) K230041 ยท FRN Pump, Infusion
Spectrum IQ Infusion System with Dose IQ Safety Software
| Applicant | Baxter Healthcare Corporation, Round Lake IL, US |
| Decision | Substantially Equivalent, Mar 31, 2023 |
| Received | Jan 6, 2023 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K230041
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 22, 2025 | Baxter Healthcare Corporation Spectrum IQ Infusion Pump, Product Code 3570009 Open, Classified |
FRN | None listed |
| Mar 6, 2025 | Baxter Healthcare Corporation Baxter Spectrum IQ Infusion System with Dose IQ Safety Software, Product Code 3570009 Open, Classified |
FRN | None listed |
| Nov 8, 2024 | Baxter Healthcare Corporation Baxter Spectrum IQ Infusion System with Dose IQ Safety Software, Product Code 3570009 Open, Classified |
FRN | None listed |
| Aug 16, 2024 | Baxter Healthcare Corporation Spectrum Wireless Battery Modules A/B/G/N, product code 36010, used with either of the following 35700BAX2 (Spectrum V8 infusion pump) and 3570009 (Spectrum IQ infusion pump) Open, Classified |
FRN | None listed |
| May 13, 2024 | Baxter Healthcare Corporation Spectrum IQ Infusion pump, Product Code 357009 Open, Classified |
FRN | None listed |
| May 3, 2024 | Baxter Healthcare Corporation Baxter Spectrum IQ Infusion Pump, Product Code 3570009 Open, Classified |
FRN | None listed |
| Jul 13, 2023 | Baxter Healthcare Corporation The Spectrum IQ Infusion System with Dose IQ Safety Software, Product Code 3570009 Open, Classified |
FRN | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.