510(k) · Cleared
ClearedPLV Continuum Ventilator, Model P2000
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Respironics California, Inc. · NOU Continuous, Ventilator, Home Use
Cleared on Mar 16, 2004 as substantially equivalent to K022750 (Respironics California, Inc., 2003) and 3 other predicates after a 78-day review. Its family tree reaches back 4 generations to 1984. 1 of the 13 devices in its family, counting itself, has a Class I recall. 1 later device descends from it.
- Decided
- Mar 16, 2004
- Review
- 78 days
- Class
- Class II
- Product code
- NOU
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 4 generations to K841279 (1984). 11 ancestors in all. 1 later device descends from it, 1 citing it directly. 1 of the 13 devices in this family, counting this one, has a Class I recall.
- Root · 4 generations backK841279 BEAR 33Bear Medical Systems, Inc. · 1984
- 3 generations backK981971 Tbird VS/Avs Volume Ventilator, Models 15568, 15570 , LP10 Volume…Bird Products Corp. · 1998
- 2 generations backK984056 LTV 1000Pulmonetic Systems, Inc. · 1999 · Recalled
- 1 generation backK022750 PLV Continuum Ventilator, Model P1000Respironics California, Inc. · 2003 · Recalled
- This deviceK034032 PLV Continuum Ventilator, Model P2000Respironics California, Inc. · 2004
- Descendant · cites it directly · 0 of its ownK081845 IVENT101Versamed Medical Systems, Inc. · 2009
Class I recalls in this family
- K981072 Esprit Ventilatordirect predicate · 1998
Most influential descendants
Showing 1 of 1 · See all- K081845IVENT101Versamed Medical Systems, Inc. · 2009 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K841279 | BEAR 33 | Bear Medical Systems, Inc. | 1984 | — |
| −3 | K981971 | Tbird VS/Avs Volume Ventilator, Models 15568, 15570 , LP10 Volume Ventilator… | Bird Products Corp. | 1998 | — |
| −2 | K984056 | LTV 1000 | Pulmonetic Systems, Inc. | 1999 | 12 |
| −1 | K022750 | PLV Continuum Ventilator, Model P1000 | Respironics California, Inc. | 2003 | 2 |
| 0 (this device) | K034032 | PLV Continuum Ventilator, Model P2000 | Respironics California, Inc. | 2004 | — |
| +1 | K081845 | IVENT101 | Versamed Medical Systems, Inc. | 2009 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1984 | 1 | 0 |
| 1989 | 1 | 0 |
| 1990 | 2 | 0 |
| 1996 | 1 | 0 |
| 1998 | 1 | 1 |
| 1999 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
1 device in this family has a Class I recall. A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new NOU device
- #1 K233452 Vivo 45 LSscore 10.6 · 14 generations · no Class I recall
- #2 Held for the reportin the report
What was it cleared against? (4)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K022750 | PLV Continuum Ventilator, Model P1000Summary page 1…ass 11 Continuous Ventilator (per 21 CFR 868.5895) Predicate * Respironics PLVC Ventilator K022750 * Respironics Esprit Ventilator K981 072 Devices:… | 2003 |
| * | K981072 | Esprit VentilatorSummary page 1…5) Predicate * Respironics PLVC Ventilator K022750 * Respironics Esprit Ventilator K981 072 Devices: *Pulmonetics LTV 1000 Ventilator K984056… | 1998 |
| * | K984056 | LTV 1000Summary page 1…* Respironics Esprit Ventilator K981 072 Devices: *Pulmonetics LTV 1000 Ventilator K984056 *NPB Achieva Ventilator K990177 16.1 Device Description:… | 1999 |
| * | K990177 | Nellcor Puritan Bennett Achieva Ventilator and Report GeneratorSummary page 1…es: *Pulmonetics LTV 1000 Ventilator K984056 *NPB Achieva Ventilator K990177 16.1 Device Description: compressor-ba… | 1999 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K081845 | IVENT101 | 2009 | 0 |
Has anything in its family been recalled? (1 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K981072Esprit VentilatorRespironics, Inc. · 1998 · Direct predicate · ◆ in the 1998 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 20 years and passes through 4 companies; a new generation was cleared every 4.6 years on median.
- 4 of the 11 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K081845 (Versamed Medical Systems, Inc., 2009) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K022750.
How does its category compare?
All NOU devicesNOU Continuous, Ventilator, Home Use: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · NOU
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · NOU
Too few NOU 510(k)s in any year since 2007 to give a median.
Recalls per year · NOU
1in 2023
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · NOU
932in 2025
MAUDE reports naming product code NOU, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 1 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 1 |
| 2013 | 1 | — | 0 | 5 |
| 2014 | 0 | — | 0 | 112 |
| 2015 | 0 | — | 0 | 1,217 |
| 2016 | 1 | — | 0 | 1,160 |
| 2017 | 0 | — | 0 | 175 |
| 2018 | 0 | — | 0 | 41 |
| 2019 | 0 | — | 0 | 37 |
| 2020 | 0 | — | 0 | 67 |
| 2021 | 1 | — | 0 | 248 |
| 2022 | 0 | — | 0 | 336 |
| 2023 | 0 | — | 1 | 1,259 |
| 2024 | 0 | — | 0 | 817 |
| 2025 | 1 | — | 0 | 932 |
| 2026 | 0 | — | 1 (1) | — |
What is it indicated for?
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K034032 · printed Nov 4, 2026
Cite this page
510(k) Report. “K034032: PLV Continuum Ventilator, Model P2000.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K034032
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026