# K230919: Acumen IQ finger cuff

- Pathway: 510(k) (Traditional)
- Applicant: Edwards Lifesciences, LLC
- Decided: Oct 24, 2023 after 204 days
- Product code: DXN (System, Measurement, Blood-Pressure, Non-Invasive)
- Device class: 2
- Regulation: 21 CFR 870.1130
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 12 generations back to K000126 (2000). 26 ancestors in all.
3 later devices descend from it; 1 cites it directly.
1 of 30 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K190130: The ClearSight finger cuffs, Edwards Lifesciences, LLC (2019) Summary page 4.

## Most influential descendants
- 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
- K253034: HemoSphere Stream Module (2025), 0 descendants of its own

## Indications for use
The Acumen™ IQ finger cuff is indicated for patients over 18 years of age to noninvasively measure blood pressure and associated hemodynamic parameters when used with the HemoSphere advanced monitoring platform.

Source page: https://510kreport.com/device/K230919
Methodology: https://510kreport.com/methodology