# K110525: Vitalograph Model 7100 - Vitalojak

- Pathway: 510(k) (Traditional)
- Applicant: Vitalograph (Ireland), Ltd.
- Decided: Nov 23, 2011 after 273 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: 5 generations back to K943862 (1995). 11 ancestors in all.
5 later devices descend from it; 2 cite it directly.
0 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K101022: Pulmotrack 5050 Wholter, Model 5050, Karmelsonix (2010) Summary page 1.

## Most influential descendants
- K201077: Strados Remote Electronic Stethoscope Platform (RESP) (2020), 3 descendants of its own
- K220893: Strados Remote Electronic Stethoscope Platform (RESP) (2022), 2 descendants of its own
- K223382: AeviceMD (2023), 1 descendant of its own
- K253293: VitaloJAK Clinic (Model 7100) (2025), 0 descendants of its own
- K243603: AeviceMD (2025), 0 descendants of its own

## Indications for use
The Model 7100 is a non-invasive battery operated device intended to acquire, record and store ambulatory cough sounds from patients for up to 24 hours. The device stores the data on a removable memory card for later playback, review, and analysis on a windows based PC.

Source page: https://510kreport.com/device/K110525
Methodology: https://510kreport.com/methodology