# K230842: SignalHF (IM008)

- Pathway: 510(k) (Traditional)
- Applicant: Implicity, Inc.
- Decided: Oct 25, 2023 after 211 days
- Product code: QNL (Medium-Term Adjunctive Predictive Cardiovascular Indicator)
- Device class: 2
- Regulation: 21 CFR 870.2210
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 28 generations back to K941811 (1994). 243 ancestors in all.
No later device cites it as a predicate yet.
1 of 244 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K203224: Acumen Hypotension Prediction Index, HemoSphere Advanced Monitoring Platform, Edwards Lifesciences, LLC (2021) Summary page 5.

## Indications for use
The SignalHF System is intended for use by qualified healthcare professionals (HCP) managing patients over 18 years old who are receiving physiological monitoring for Heart Failure surveillance and implanted with a compatible Cardiac Implantable Electronic Devices (CIED) (i.e., compatible pacemakers, ICDs, and CRTs). The SignalHF System provides additive information to use in conjunction with standard clinical evaluation. The SignalHF HF Score is intended to calculate the risk of HF for a patient in the next 30 days. This System is intended for adjunctive use with other physiological vital signs and patient symptoms and information and is not intended to independently direct therapy.

Source page: https://510kreport.com/device/K230842
Methodology: https://510kreport.com/methodology