510(k) K193483 ยท QJS Interoperable Automated Glycemic Controller, Insulin Suspend
Basal-IQ Technology
| Applicant | Tandem Diabetes Care, Inc., San Diego CA, US |
| Decision | Substantially Equivalent, Feb 28, 2020 |
| Received | Dec 17, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K193483
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 27, 2025 | Tandem Diabetes Care, Inc. Battery Operated infusion pumps. t:slim X2 G5, Replacement, Refurbished, REF: 1000911;
t:slim X2 GS Classic, Replacement, Refurbished, REF: 1003808;
t: slim X2, Basal-IQ, mg/dl, REF: 1004219;
Pump, t: Open, Classified |
QFG | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.