# K230612: Edwards Algorithm for Measurement of Blood Hemoglobin

- Pathway: 510(k) (Traditional)
- Applicant: Edwards Lifesciences, LLC
- Decided: Nov 17, 2023 after 256 days
- Product code: MUD (Oximeter, Tissue Saturation)
- Device class: 2
- Regulation: 21 CFR 870.2700
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 30 generations back to K941811 (1994). 248 ancestors in all.
5 later devices descend from it; 1 cites it directly.
1 of 254 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K223127: HemoSphere Advanced Monitoring Platform, HemoSphere ForeSight Oximeter cable, Edwards Lifeciences, LLC (2022) Summary page 4.

## Most influential descendants
- K242451: HemoSphere Alta Advanced Monitoring Platform (ALTAALL1/ALTCR1/ALTASR1); HemoSphere Alta- monitor pressure cable (HEMAPSC200);Acumen AFM cable- HemoSphere Alta monitor (HEMAFM100) (2024), 4 descendants of its own
- K243781: 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 (HEMVTOM1); HemoSphere VitaWave module (HEMVWM1); VitaWave Plus finger cuff (VWCA2) (2025), 2 descendants of its own
- K253186: HemoSphere Nano Monitor (HSNANO1) (2026), 0 descendants of its own
- K252533: HemoSphere Alta Advanced Monitoring Platform (ALTAALL1; ALTACR1; ALTASR1) (2025), 0 descendants of its own
- K253034: HemoSphere Stream Module (2025), 0 descendants of its own

## Indications for use
The Edwards Algorithm for Measurement of Blood Hemoglobin is indicated for continuously monitoring changes to hemoglobin concentration in the circulating blood of adults ≥ 40 kg receiving advanced hemodynamic monitoring using HemoSphere ForeSight Oximeter Cable and non-invasive ForeSight sensors (large) in cerebral locations.

Source page: https://510kreport.com/device/K230612
Methodology: https://510kreport.com/methodology