# K253293: VitaloJAK Clinic (Model 7100)

- Pathway: 510(k) (Special)
- Applicant: Vitalograph, Ltd.
- Decided: Dec 3, 2025 after 65 days
- Product code: DSH (Recorder, Magnetic Tape, Medical)
- Device class: 2
- Regulation: 21 CFR 870.2800
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K943862 (1995). 12 ancestors in all.
No later device cites it as a predicate yet.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K110525: Vitalograph Model 7100 - Vitalojak, Vitalograph (Ireland), Ltd. (2011) Summary page 6.

## Indications for use
Vitalograph VitaloJAK Clinic Model 7100 is indicated for use to aid in the assessment of cough in adults and pediatric patients aged 8 years and older under supervision presenting with suspected Chronic Cough. The Vitalograph VitaloJAK Clinic Model 7100 is a non-invasive battery-operated device intended to acquire, record and store ambulatory cough sounds from patients. The device stores the data on internal memory for later playback, review, and analysis on a windows-based PC.

Source page: https://510kreport.com/device/K253293
Methodology: https://510kreport.com/methodology