# K173973: TV-100

- Pathway: 510(k) (Traditional)
- Applicant: Bio-Med Devices, Inc.
- Decided: Jul 20, 2018 after 203 days
- Product code: CBK (Ventilator, Continuous, Facility Use)
- Device class: 2
- Regulation: 21 CFR 868.5895
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K942938 (1995). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K942938: Crossvent-4 Ventilator, Bio-Med Devices, Inc. (1995) Summary page 4.

## Indications for use
The TV-100 is intended for use by qualified medical personnel to provide intermittent to continuous ventilatory support to neonatal, pediatric, and adult patients. The TV-100 is intended for use in both invasive and non-invasive ventilation modes. The TV-100 is intended for use in hospital including intra-hospital transport, pre-hospital, and air transport settings.

Source page: https://510kreport.com/device/K173973
Methodology: https://510kreport.com/methodology