510(k) K243781 ยท DQK Computer, Diagnostic, Programmable
HemoSphere Advanced Monitor (HEM1); HemoSphere Technology Module (HEMTOM10); HemoSphere ClearSight Module (HEMCSM10); Smart Pressure Controller (PC1Q); Acumen IQ Plus Finger Cuff (AIQCA2); HemoSphere Pressure Cable (HEMPSC100); HemoSphere Vita Monitor (HEMVITA1); HemoSphere Vita Technology Module (H
| Applicant | Edwards Lifesciences, Irvine CA, US |
| Decision | Substantially Equivalent, Jul 23, 2025 |
| Received | Dec 9, 2024 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K243781
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 21, 2026 | Becton, Dickinson and Company ForeSight Elite Tissue Oximetry Cable REF HEMFSM10
UDI-DI code: 00690103210927
The non-invasive ForeSight oximeter cable is intended for use as an adjunct monitor of absolute regional hemoglobin oxyg Open, Classified |
MUD | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.