# K152305: Nihon Kohden Afib Detection Program QP-039P

- Pathway: 510(k) (Abbreviated)
- Applicant: Nihon Kohden Corporation
- Decided: Apr 8, 2016 after 238 days
- Product code: DSI (Detector And Alarm, Arrhythmia)
- Device class: 2
- Regulation: 21 CFR 870.1025
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 14 generations back to K941811 (1994). 102 ancestors in all.
No later device cites it as a predicate yet.
0 of 103 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K964122: HP Star ST and Arrhhythmia Software, Hewlett-Packard Co. (1997) Summary page 4.
- K080461: Star ST and Arrhythmia Software, Release J.0, Philips Medical Systems (2008) Summary page 4.

## Indications for use
The intended use of Afib detection program (QP-039P software) is used for processing adult patient ECG and detecting if atrial fibrillation (AF) is present continuously for more than 2.5 minutes. QP-039P software is intended to be used by qualified health care professionals in hospital or clinical environment.

Source page: https://510kreport.com/device/K152305
Methodology: https://510kreport.com/methodology