# K034032: PLV Continuum Ventilator, Model P2000

- Pathway: 510(k) (Traditional)
- Applicant: Respironics California, Inc.
- Decided: Mar 16, 2004 after 78 days
- Product code: NOU (Continuous, Ventilator, Home 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: 4 generations back to K841279 (1984). 11 ancestors in all.
1 later device descends from it; 1 cites it directly.
1 of 13 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K022750: PLV Continuum Ventilator, Model P1000, Respironics California, Inc. (2003) Summary page 1.
- K981072: Esprit Ventilator, Respironics, Inc. (1998) Summary page 1.
- K984056: LTV 1000, Pulmonetic Systems, Inc. (1999) Summary page 1.
- K990177: Nellcor Puritan Bennett Achieva Ventilator and Report Generator, Nellcor Puritan Bennett, Inc. (1999) Summary page 1.

## Most influential descendants
- K081845: IVENT101 (2009), 0 descendants of its own

## Indications for use
The intended use of the PLV Continuum II 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 lbs). The PLV Continuum II 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/K034032
Methodology: https://510kreport.com/methodology