510(k) · Cleared
Recalled · 2004LTV-1000 Ventilator
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Pulmonetic Systems, Inc. · CBK Ventilator, Continuous, Facility Use
Cleared on Oct 16, 2003 after an 87-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 19 of the 60 devices in its family, counting itself, have a Class I recall. 59 later devices descend from it. It has been recalled once.
- Decided
- Oct 16, 2003
- Review
- 87 days
- Class
- Class II
- Product code
- CBK
- Recalls
- 1
- Predicates
- 0
59 later devices descend from it, 4 citing it directly. 19 of the 60 devices in this family, counting this one, have a Class I recall.
- This deviceK032226 LTV-1000 VentilatorPulmonetic Systems, Inc. · 2003
- Descendant · cites it directly · 57 of its ownK051767 LTV 1000 VentilatorPulmonetic Systems, Inc. · 2005
- Descendant · 2 generations on · 29 of its ownK060647 LTV 1200 VentilatorPulmonetic Systems, Inc. · 2006
- 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 · 12 of its ownK070594 Palmtop Ventilator, Models PTV-8, PTV-10Pulmonetic Systems, Inc. · 2007 · Recalled (Class I)
Showing 5 of 59 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 59 · See all- K051767LTV 1000 VentilatorPulmonetic Systems, Inc. · 2005 · cites it directly57descendants
- K060647LTV 1200 VentilatorPulmonetic Systems, Inc. · 2006 · 2 generations on29descendants
- K083526Trilogy 100 VentilatorRespironics Inc., Sleep & Home Respiratory Group · 2009 · 2 generations on26descendants
- K093416Trilogy 200 VentilatorRespironics, Inc. · 2010 · 3 generations on19descendants
- K070594Palmtop Ventilator, Models PTV-8, PTV-10Pulmonetic Systems, Inc. · 2007 · 3 generations on12descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K032226 | LTV-1000 Ventilator | Pulmonetic Systems, Inc. | 2003 | — |
| +1 | K051767 | LTV 1000 Ventilator | Pulmonetic Systems, Inc. | 2005 | — |
| +2 | K060647 | LTV 1200 Ventilator | Pulmonetic Systems, Inc. | 2006 | — |
| +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 | K070594 | Palmtop Ventilator, Models PTV-8, PTV-10 | Pulmonetic Systems, Inc. | 2007 | Class I |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 2 | 2 |
| 2008 | 2 | 0 |
| 2009 | 5 | 2 |
| 2010 | 5 | 1 |
| 2011 | 6 | 2 |
| 2012 | 7 | 2 |
| 2013 | 3 | 1 |
| 2014 | 3 | 0 |
| 2015 | 1 | 0 |
| 2016 | 6 | 2 |
| 2017 | 3 | 3 |
| 2018 | 1 | 1 |
| 2019 | 3 | 2 |
| 2021 | 2 | 1 |
| 2024 | 4 | 0 |
| 2025 | 2 | 0 |
| 2026 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
19 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’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (59)
See all 594 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (19 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Sep 8, 2004 | Not classified | Z-1485-04 | Other | Ventilators have not consistently switched to internal battery operation when the external DC power source has become inadequate to supply stable power. This situation results in loss of ventilation to the patient. |
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.
- K090888Newport HT70 Family of VentilatorsNewport Medical Instruments, Inc. · 2009 · Cites it directly · ◆ in the 2009 descendants bar of FIG. 13 Class I recalls
- K083526Trilogy 100 VentilatorRespironics Inc., Sleep & Home Respiratory Group · 2009 · 2 generations on · ◆ in the 2009 descendants bar of FIG. 15 Class I recalls
- K070899Puritan Bennett Legendair XL2Nellcor Puritan Bennett · 2007 · 2 generations on · ◆ in the 2007 descendants bar of FIG. 11 Class I recall
- K111146Newport HT70 VentilatorNewport Medical Instruments, Inc. · 2011 · 2 generations on · ◆ in the 2011 descendants bar of FIG. 14 Class I recalls
- K070594Palmtop Ventilator, Models PTV-8, PTV-10Pulmonetic Systems, Inc. · 2007 · 3 generations on · ◆ in the 2007 descendants bar of FIG. 12 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
- K162877VOCSN Unified Respiratory SystemVentec Life Systems, Inc. · 2017 · 4 generations on · ◆ in the 2017 descendants bar of FIG. 114 Class I recalls
- K162832731 Series VentilatorsZOLL Medical Corporation · 2017 · 4 generations on · ◆ in the 2017 descendants bar of FIG. 11 Class I recall
- 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
Nearest 12 of 19 shown.
Nearest 5 of 19; all are on the web page.
What does this lineage say?
- Of its descendants, K051767 (Pulmonetic Systems, Inc., 2005) has gone furthest, with 57 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) | — |
What is it indicated for?
The LTV 1000 ventilator is intended to provide continuous or intermittent ventilatory support for the care of individuals who require mechanical ventilation. The ventilator is a restricted medical device intended for use by qualified, trained personnel under the direction of a physician. Specifically, the ventilator is applicable for adult and pediatric patients weighing at least 5 kg (11 Ibs), who require the following types of ventilatory support:
Positive Pressure Ventilation, delivered invasively (via ET tube) or non-invasively (via mask).
Assist/Control, SIMV, or CPAP modes of ventilation.
The ventilator is suitable for use in institutional, home, or transport settings.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K032226 · printed Nov 6, 2026
Cite this page
510(k) Report. “K032226: LTV-1000 Ventilator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K032226
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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