# K842876: Portable Lifecare Ventilator PLV-102

- Pathway: 510(k) (Traditional)
- Applicant: Lifecare Services, Inc.
- Decided: Aug 29, 1984 after 37 days
- Product code: CBK (Ventilator, Continuous, Facility Use)
- Device class: 2
- Regulation: 21 CFR 868.5895
- Recalls of this device: 9 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
30 later devices descend from it; 1 cites it directly.
11 of 31 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K022750: PLV Continuum Ventilator, Model P1000 (2003), 29 descendants of its own
- K083526: Trilogy 100 Ventilator (2009), 26 descendants of its own
- K093416: Trilogy 200 Ventilator (2010), 19 descendants of its own
- K111610: Trilogy Series Ventilator with Oximetry (2011), 11 descendants of its own
- K133868: Astral Ventilator (2014), 10 descendants of its own

## Recalls of this device
- Oct 15, 2007 · Not classified · Z-1060-2008: Foreign material: Glass fragments may present in the plastic bag material used to ship components.
- Oct 15, 2007 · Not classified · Z-1056-2008: Foreign material: Glass fragments may present in the plastic bag material used to ship components.
- Oct 15, 2007 · Not classified · Z-1058-2008: Foreign material: Glass fragments may present in the plastic bag material used to ship components.
- Oct 15, 2007 · Not classified · Z-1062-2008: Foreign material: Glass fragments may present in the plastic bag material used to ship components.
- Oct 15, 2007 · Not classified · Z-1070-2008: Foreign material: Glass fragments may present in the plastic bag material used to ship components.
- Oct 15, 2007 · Not classified · Z-1080-2008: Foreign material: Glass fragments may present in the plastic bag material used to ship components.
- Oct 15, 2007 · Not classified · Z-1085-2008: Foreign material: Glass fragments may present in the plastic bag material used to ship components.
- Oct 15, 2007 · Not classified · Z-1082-2008: Foreign material: Glass fragments may present in the plastic bag material used to ship components.
- Oct 15, 2007 · Not classified · Z-1077-2008: Foreign material: Glass fragments may present in the plastic bag material used to ship components.

Source page: https://510kreport.com/device/K842876
Methodology: https://510kreport.com/methodology