# K101022: Pulmotrack 5050 Wholter, Model 5050

- Pathway: 510(k) (Traditional)
- Applicant: Karmelsonix
- Decided: Jul 9, 2010 after 87 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: 4 generations back to K943862 (1995). 10 ancestors in all.
6 later devices descend from it; 1 cites 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)
- K071955: Wim-PC, Model 1010, Karmelsonix (2007) Summary page 2.
- K083820: Vasomedical Biox CB-1305-C, 3 Channel Ecg Holter Monitor, Model CB-1305-C, Vasomedical, Inc. (2009) Summary page 2.

## Most influential descendants
- K110525: Vitalograph Model 7100 - Vitalojak (2011), 5 descendants of its own
- 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

## Indications for use
The PulmoTrack 5050 WholterTM is a non-invasive device intended to acquire, record and store ambulatory respiratory activity from patients for up to 24 hours. It works in concert with the PulmoTrack® Series for playback, review, analysis, editing and printing of respiratory data. The Pulmo Track 5050 WholterTm is indicated for but not limited to recording of signals that reflect symptoms such as wheeze and cough.

Source page: https://510kreport.com/device/K101022
Methodology: https://510kreport.com/methodology