# K022750: PLV Continuum Ventilator, Model P1000

- Pathway: 510(k) (Traditional)
- Applicant: Respironics California, Inc.
- Decided: Nov 20, 2003 after 458 days
- Product code: NOU (Continuous, Ventilator, Home Use)
- Device class: 2
- Regulation: 21 CFR 868.5895
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K841279 (1984). 7 ancestors in all.
29 later devices descend from it; 2 cite it directly.
12 of 37 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K842876: Portable Lifecare Ventilator PLV-102, Lifecare Services, Inc. (1984) Summary page 1.
- K981072: Esprit Ventilator, Respironics, Inc. (1998) Summary page 1.
- K984056: LTV 1000, Pulmonetic Systems, Inc. (1999) Summary page 1.

## Most influential descendants
- 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
- K112754: IVENT101 (2012), 9 descendants of its own

## Recalls of this device
- Mar 20, 2006 · Not classified · Z-0808-06: Flow valve failures- When failure occurs, air flow from the ventilator ceases resulting in the PLVC I transitioning into a 'Vent Inop' mode whereby the safety valve is activated, opening the circuit t
- Nov 18, 2005 · Not classified · Z-0354-06: During product testing of the PLV Continuum Ventilator's Safety Valve/Pressure Relief Valve (SV/PRV) at our manufacturing facility, Respironics found that when the PLY Continuum Ventilator is operated

## Indications for use
The intended use of the PLV Continuum ventilator is to provide continuous or intermittent ventilatory support for the care of individuals who require mechanical ventilation. The intended patient population includes pediatric and adult patients who weigh at least 5 kg (11 Ibs). The PLV Continuum ventilator is intended for use in home, institutional and portable settings and may be used for invasive as well as non-invasive ventilation.

Source page: https://510kreport.com/device/K022750
Methodology: https://510kreport.com/methodology