510(k) · Cleared
Recalled · 2007Portable Lifecare Ventilator PLV-102
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Lifecare Services, Inc. · CBK Ventilator, Continuous, Facility Use
Cleared on Aug 29, 1984 after a 37-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 11 of the 31 devices in its family, counting itself, have a Class I recall. 30 later devices descend from it. It has been recalled 9 times.
- Decided
- Aug 29, 1984
- Review
- 37 days
- Class
- Class II
- Product code
- CBK
- Recalls
- 9
- Predicates
- 0
30 later devices descend from it, 1 citing it directly. 11 of the 31 devices in this family, counting this one, have a Class I recall.
- This deviceK842876 Portable Lifecare Ventilator PLV-102Lifecare Services, Inc. · 1984
- Descendant · cites it directly · 29 of its ownK022750 PLV Continuum Ventilator, Model P1000Respironics California, Inc. · 2003 · Recalled
- Descendant · 2 generations on · 26 of its ownK083526 Trilogy 100 VentilatorRespironics Inc., Sleep & Home Respiratory Group · 2009 · Recalled (Class I)
- Descendant · 3 generations on · 19 of its ownK093416 Trilogy 200 VentilatorRespironics, Inc. · 2010 · Recalled (Class I)
- Descendant · 3 generations on · 11 of its ownK111610 Trilogy Series Ventilator with OximetryRespironics, Inc. · 2011 · Recalled (Class I)
- Descendant · 4 generations on · 10 of its ownK133868 Astral VentilatorResmed, Ltd. · 2014 · Recalled
Showing 5 of 30 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 30 · See all- K022750PLV Continuum Ventilator, Model P1000Respironics California, Inc. · 2003 · cites it directly29descendants
- K083526Trilogy 100 VentilatorRespironics Inc., Sleep & Home Respiratory Group · 2009 · 2 generations on26descendants
- K093416Trilogy 200 VentilatorRespironics, Inc. · 2010 · 3 generations on19descendants
- K111610Trilogy Series Ventilator with OximetryRespironics, Inc. · 2011 · 3 generations on11descendants
- K133868Astral VentilatorResmed, Ltd. · 2014 · 4 generations on10descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K842876 | Portable Lifecare Ventilator PLV-102 | Lifecare Services, Inc. | 1984 | — |
| +1 | K022750 | PLV Continuum Ventilator, Model P1000 | Respironics California, Inc. | 2003 | 2 |
| +2 | K083526 | Trilogy 100 Ventilator | Respironics Inc., Sleep & Home Respiratory Group | 2009 | Class I |
| +3 | K093416 | Trilogy 200 Ventilator | Respironics, Inc. | 2010 | Class I |
| +3 | K111610 | Trilogy Series Ventilator with Oximetry | Respironics, Inc. | 2011 | Class I |
| +4 | K133868 | Astral Ventilator | Resmed, Ltd. | 2014 | 2 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 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), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
11 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 CBK device
- #1 K252663 Inbentus Versatilescore 16.0 · 17 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (30)
See all 301 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K022750 | PLV Continuum Ventilator, Model P1000 | 2003 | 29 |
Has anything in its family been recalled? (11 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Oct 15, 2007 | Not classified | Z-1060-2008 | Environmental control | Foreign material: Glass fragments may present in the plastic bag material used to ship components. |
| Oct 15, 2007 | Not classified | Z-1056-2008 | Environmental control | Foreign material: Glass fragments may present in the plastic bag material used to ship components. |
| Oct 15, 2007 | Not classified | Z-1058-2008 | Environmental control | Foreign material: Glass fragments may present in the plastic bag material used to ship components. |
| Oct 15, 2007 | Not classified | Z-1062-2008 | Environmental control | Foreign material: Glass fragments may present in the plastic bag material used to ship components. |
| Oct 15, 2007 | Not classified | Z-1070-2008 | Environmental control | Foreign material: Glass fragments may present in the plastic bag material used to ship components. |
| Oct 15, 2007 | Not classified | Z-1080-2008 | Environmental control | Foreign material: Glass fragments may present in the plastic bag material used to ship components. |
| Oct 15, 2007 | Not classified | Z-1085-2008 | Environmental control | Foreign material: Glass fragments may present in the plastic bag material used to ship components. |
| Oct 15, 2007 | Not classified | Z-1082-2008 | Environmental control | Foreign material: Glass fragments may present in the plastic bag material used to ship components. |
| Oct 15, 2007 | Not classified | Z-1077-2008 | Environmental control | Foreign material: Glass fragments may present in the plastic bag material used to ship components. |
The 5 latest of 9 recalls; the web page lists all.
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.
- K083526Trilogy 100 VentilatorRespironics Inc., Sleep & Home Respiratory Group · 2009 · 2 generations on · ◆ in the 2009 descendants bar of FIG. 15 Class I recalls
- K093416Trilogy 200 VentilatorRespironics, Inc. · 2010 · 3 generations on · ◆ in the 2010 descendants bar of FIG. 14 Class I recalls
- K111610Trilogy Series Ventilator with OximetryRespironics, Inc. · 2011 · 3 generations on · ◆ in the 2011 descendants bar of FIG. 12 Class I recalls
- K121623Bipap a 40 Ventilatory Support SystemRespironics, Inc. · 2012 · 4 generations on · ◆ in the 2012 descendants bar of FIG. 13 Class I recalls
- K181170Trilogy Evo UniversalRespironics, Inc. · 2019 · 4 generations on · ◆ in the 2019 descendants bar of FIG. 112 Class I recalls
- K181166Trilogy EvoRespironics, Inc. · 2019 · 4 generations on · ◆ in the 2019 descendants bar of FIG. 131 Class I recalls
- K122715Stellar 150Resmed Germany, Inc. · 2013 · 4 generations on · ◆ in the 2013 descendants bar of FIG. 11 Class I recall
- K162877VOCSN Unified Respiratory SystemVentec Life Systems, Inc. · 2017 · 4 generations on · ◆ in the 2017 descendants bar of FIG. 114 Class I recalls
- K152068Astral 100/150Resmed, Ltd. · 2016 · 5 generations on · ◆ in the 2016 descendants bar of FIG. 11 Class I recall
- K193586Vivo 45 LSBreas Medical AB · 2021 · 5 generations on · ◆ in the 2021 descendants bar of FIG. 11 Class I recall
- K172875Astral 100/150Resmed, Ltd. · 2018 · 6 generations on · ◆ in the 2018 descendants bar of FIG. 12 Class I recalls
Nearest 5 of 11; all are on the web page.
What does this lineage say?
- Of its descendants, K022750 (Respironics California, Inc., 2003) has gone furthest, with 29 descendants of its own.
How does its category compare?
All CBK devicesCBK Ventilator, Continuous, Facility Use: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · CBK
4in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · CBK
163in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · CBK
14in 2024
Class I (81 since 2007) Class II/III not classified
Adverse event reports per year · CBK
13,991in 2025
MAUDE reports naming product code CBK, 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 | 11 | 142 | 17 | 1,531 |
| 2008 | 18 | 115 | 23 | 1,933 |
| 2009 | 12 | 122 | 8 | 1,766 |
| 2010 | 14 | 150 | 9 | 1,799 |
| 2011 | 13 | 192 | 12 | 1,877 |
| 2012 | 17 | 207 | 2 (1) | 5,509 |
| 2013 | 5 | 277 | 5 (2) | 7,921 |
| 2014 | 5 | 439 | 5 (4) | 7,600 |
| 2015 | 7 | 266 | 6 (4) | 11,876 |
| 2016 | 4 | 323 | 4 (1) | 16,056 |
| 2017 | 6 | 280 | 1 | 14,451 |
| 2018 | 4 | 183 | 3 (3) | 9,849 |
| 2019 | 8 | 435 | 14 (13) | 9,100 |
| 2020 | 5 | 176 | 4 | 11,096 |
| 2021 | 6 | 267 | 21 (19) | 13,322 |
| 2022 | 0 | — | 8 (4) | 15,974 |
| 2023 | 5 | 309 | 4 (3) | 24,928 |
| 2024 | 9 | 203 | 14 (14) | 20,336 |
| 2025 | 4 | 163 | 0 | 13,991 |
| 2026 | 3 | 235 | 15 (13) | — |
https://510kreport.com/device/K842876 · printed Nov 4, 2026
Cite this page
510(k) Report. “K842876: Portable Lifecare Ventilator PLV-102.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K842876
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026