510(k) · Cleared
Recalled · 2006PLV Continuum Ventilator, Model P1000
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 Nov 20, 2003 as substantially equivalent to K842876 (Lifecare Services, Inc., 1984) and 2 other predicates after a 458-day review. Its family tree reaches back 3 generations to 1984. 12 of the 37 devices in its family, counting itself, have a Class I recall. 29 later devices descend from it. It has been recalled 2 times.
- Decided
- Nov 20, 2003
- Review
- 458 days
- Class
- Class II
- Product code
- NOU
- Recalls
- 2
- Predicates
- 3
Its longest line of descent runs back 3 generations to K841279 (1984). 7 ancestors in all. 29 later devices descend from it, 2 citing it directly. 12 of the 37 devices in this family, counting this one, have a Class I recall.
- Root · 3 generations backK841279 BEAR 33Bear Medical Systems, Inc. · 1984
- 2 generations backK981971 Tbird VS/Avs Volume Ventilator, Models 15568, 15570 , LP10 Volume…Bird Products Corp. · 1998
- 1 generation backK984056 LTV 1000Pulmonetic Systems, Inc. · 1999 · Recalled
- This deviceK022750 PLV Continuum Ventilator, Model P1000Respironics California, Inc. · 2003
- Descendant · cites it directly · 26 of its ownK083526 Trilogy 100 VentilatorRespironics Inc., Sleep & Home Respiratory Group · 2009 · Recalled (Class I)
- Descendant · 2 generations on · 19 of its ownK093416 Trilogy 200 VentilatorRespironics, Inc. · 2010 · Recalled (Class I)
- Descendant · 2 generations on · 11 of its ownK111610 Trilogy Series Ventilator with OximetryRespironics, Inc. · 2011 · Recalled (Class I)
- Descendant · 3 generations on · 10 of its ownK133868 Astral VentilatorResmed, Ltd. · 2014 · Recalled
- Descendant · 2 generations on · 9 of its ownK112754 IVENT101Versamed Medical Systems, Ltd. · 2012
Showing 5 of 29 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 29 · See all- K083526Trilogy 100 VentilatorRespironics Inc., Sleep & Home Respiratory Group · 2009 · cites it directly26descendants
- K093416Trilogy 200 VentilatorRespironics, Inc. · 2010 · 2 generations on19descendants
- K111610Trilogy Series Ventilator with OximetryRespironics, Inc. · 2011 · 2 generations on11descendants
- K133868Astral VentilatorResmed, Ltd. · 2014 · 3 generations on10descendants
- K112754IVENT101Versamed Medical Systems, Ltd. · 2012 · 2 generations on9descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K841279 | BEAR 33 | Bear Medical Systems, Inc. | 1984 | — |
| −2 | K981971 | Tbird VS/Avs Volume Ventilator, Models 15568, 15570 , LP10 Volume Ventilator… | Bird Products Corp. | 1998 | — |
| −1 | K984056 | LTV 1000 | Pulmonetic Systems, Inc. | 1999 | 12 |
| 0 (this device) | K022750 | PLV Continuum Ventilator, Model P1000 | Respironics California, Inc. | 2003 | — |
| +1 | K083526 | Trilogy 100 Ventilator | Respironics Inc., Sleep & Home Respiratory Group | 2009 | Class I |
| +2 | K093416 | Trilogy 200 Ventilator | Respironics, Inc. | 2010 | Class I |
| +2 | K111610 | Trilogy Series Ventilator with Oximetry | Respironics, Inc. | 2011 | Class I |
| +3 | K133868 | Astral Ventilator | Resmed, Ltd. | 2014 | 2 |
| +2 | K112754 | IVENT101 | Versamed Medical Systems, Ltd. | 2012 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1984 | 1 | 0 |
| 1990 | 1 | 0 |
| 1996 | 1 | 0 |
| 1998 | 1 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2009 | 2 | 1 |
| 2010 | 1 | 1 |
| 2011 | 1 | 1 |
| 2012 | 5 | 1 |
| 2013 | 2 | 1 |
| 2014 | 2 | 0 |
| 2016 | 4 | 1 |
| 2017 | 1 | 1 |
| 2018 | 1 | 1 |
| 2019 | 3 | 2 |
| 2021 | 1 | 1 |
| 2024 | 3 | 0 |
| 2025 | 2 | 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.
12 devices in this family have 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? (3)
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 |
|---|---|---|---|
| * | K842876 | Portable Lifecare Ventilator PLV-102Summary page 1…Classification: Class I I Continuous Ventilator (per 21 CFR 868.5895) Predicate 0 Respironics PLV-102 Ventilator K842876 Devices: 0 Respironics Esprit Ventilator K981072 0 Pulmonetic Systems LTV 1… | 1984 |
| * | K981072 | Esprit VentilatorSummary page 1…ilator (per 21 CFR 868.5895) Predicate 0 Respironics PLV-102 Ventilator K842876 Devices: 0 Respironics Esprit Ventilator K981072 0 Pulmonetic Systems LTV 1000 K984056 Ventilator 16.1 Devi… | 1998 |
| * | K984056 | LTV 1000Summary page 1…LV-102 Ventilator K842876 Devices: 0 Respironics Esprit Ventilator K981072 0 Pulmonetic Systems LTV 1000 K984056 Ventilator 16.1 Device Description: The PLV Continuum ventilator is a microprocessor co… | 1999 |
What descends from it? (29)
See all 292 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (12 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Mar 20, 2006 | Not classified | Z-0808-06 | Other | 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 to ambient air. Ventilator dependent… |
| Nov 18, 2005 | Not classified | Z-0354-06 | Other | 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 in the 'Face Up' orientation, the SV… |
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
- K083526Trilogy 100 VentilatorRespironics Inc., Sleep & Home Respiratory Group · 2009 · Cites it directly · ◆ in the 2009 descendants bar of FIG. 15 Class I recalls
- K093416Trilogy 200 VentilatorRespironics, Inc. · 2010 · 2 generations on · ◆ in the 2010 descendants bar of FIG. 14 Class I recalls
- K111610Trilogy Series Ventilator with OximetryRespironics, Inc. · 2011 · 2 generations on · ◆ in the 2011 descendants bar of FIG. 12 Class I recalls
- K121623Bipap a 40 Ventilatory Support SystemRespironics, Inc. · 2012 · 3 generations on · ◆ in the 2012 descendants bar of FIG. 13 Class I recalls
- K181170Trilogy Evo UniversalRespironics, Inc. · 2019 · 3 generations on · ◆ in the 2019 descendants bar of FIG. 112 Class I recalls
- K181166Trilogy EvoRespironics, Inc. · 2019 · 3 generations on · ◆ in the 2019 descendants bar of FIG. 131 Class I recalls
- K122715Stellar 150Resmed Germany, Inc. · 2013 · 3 generations on · ◆ in the 2013 descendants bar of FIG. 11 Class I recall
- K162877VOCSN Unified Respiratory SystemVentec Life Systems, Inc. · 2017 · 3 generations on · ◆ in the 2017 descendants bar of FIG. 114 Class I recalls
- K152068Astral 100/150Resmed, Ltd. · 2016 · 4 generations on · ◆ in the 2016 descendants bar of FIG. 11 Class I recall
- K193586Vivo 45 LSBreas Medical AB · 2021 · 4 generations on · ◆ in the 2021 descendants bar of FIG. 11 Class I recall
- K172875Astral 100/150Resmed, Ltd. · 2018 · 5 generations on · ◆ in the 2018 descendants bar of FIG. 12 Class I recalls
Nearest 5 of 12; all are on the web page.
What does this lineage say?
- The line of descent spans 19 years and passes through 4 companies; a new generation was cleared every 4.6 years on median.
- 3 of the 7 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K083526 (Respironics Inc., Sleep & Home Respiratory Group, 2009) has gone furthest, with 26 descendants of its own.
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 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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K022750 · printed Nov 4, 2026
Cite this page
510(k) Report. “K022750: PLV Continuum Ventilator, Model P1000.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K022750
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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