510(k) · Cleared
Recalled · 2008LTV 1000
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 Apr 12, 1999 as substantially equivalent to K981971 (Bird Products Corp., 1998) after a 150-day review. Its family tree reaches back 2 generations to 1984. 16 of the 45 devices in its family, counting itself, have a Class I recall. 40 later devices descend from it. It has been recalled 12 times.
- Decided
- Apr 12, 1999
- Review
- 150 days
- Class
- Class II
- Product code
- CBK
- Recalls
- 12
- Predicates
- 1
Its longest line of descent runs back 2 generations to K841279 (1984). 4 ancestors in all. 40 later devices descend from it, 7 citing it directly. 16 of the 45 devices in this family, counting this one, have a Class I recall.
- Root · 2 generations backK841279 BEAR 33Bear Medical Systems, Inc. · 1984
- 1 generation backK981971 Tbird VS/Avs Volume Ventilator, Models 15568, 15570 , LP10 Volume…Bird Products Corp. · 1998
- This deviceK984056 LTV 1000Pulmonetic Systems, Inc. · 1999
- Descendant · cites it directly · 29 of its ownK022750 PLV Continuum Ventilator, Model P1000Respironics California, Inc. · 2003 · Recalled
- 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 · cites it directly · 12 of its ownK070594 Palmtop Ventilator, Models PTV-8, PTV-10Pulmonetic Systems, Inc. · 2007 · Recalled (Class I)
- Descendant · 2 generations on · 11 of its ownK111610 Trilogy Series Ventilator with OximetryRespironics, Inc. · 2011 · Recalled (Class I)
Showing 5 of 40 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 40 · See all- K022750PLV Continuum Ventilator, Model P1000Respironics California, Inc. · 2003 · cites it directly29descendants
- K083526Trilogy 100 VentilatorRespironics Inc., Sleep & Home Respiratory Group · 2009 · cites it directly26descendants
- K093416Trilogy 200 VentilatorRespironics, Inc. · 2010 · 2 generations on19descendants
- K070594Palmtop Ventilator, Models PTV-8, PTV-10Pulmonetic Systems, Inc. · 2007 · cites it directly12descendants
- K111610Trilogy Series Ventilator with OximetryRespironics, Inc. · 2011 · 2 generations on11descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K841279 | BEAR 33 | Bear Medical Systems, Inc. | 1984 | — |
| −1 | K981971 | Tbird VS/Avs Volume Ventilator, Models 15568, 15570 , LP10 Volume Ventilator… | Bird Products Corp. | 1998 | — |
| 0 (this device) | K984056 | LTV 1000 | Pulmonetic Systems, Inc. | 1999 | — |
| +1 | K022750 | PLV Continuum Ventilator, Model P1000 | Respironics California, Inc. | 2003 | 2 |
| +1 | K083526 | Trilogy 100 Ventilator | Respironics Inc., Sleep & Home Respiratory Group | 2009 | Class I |
| +2 | K093416 | Trilogy 200 Ventilator | Respironics, Inc. | 2010 | Class I |
| +1 | K070594 | Palmtop Ventilator, Models PTV-8, PTV-10 | Pulmonetic Systems, Inc. | 2007 | Class I |
| +2 | K111610 | Trilogy Series Ventilator with Oximetry | Respironics, Inc. | 2011 | Class I |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 1 | 0 |
| 1996 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2007 | 1 | 1 |
| 2008 | 2 | 1 |
| 2009 | 3 | 2 |
| 2010 | 2 | 1 |
| 2011 | 3 | 2 |
| 2012 | 6 | 1 |
| 2013 | 2 | 1 |
| 2014 | 2 | 0 |
| 2016 | 4 | 1 |
| 2017 | 2 | 2 |
| 2018 | 1 | 1 |
| 2019 | 3 | 2 |
| 2021 | 1 | 1 |
| 2024 | 4 | 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.
16 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? (1)
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 |
|---|---|---|---|
| * | K981971 | Tbird VS/Avs Volume Ventilator, Models 15568, 15570 , LP10 Volume Ventilator with…Summary page 1…LTV 1000 Common Name Ventilator Classification Name: Ventilator, Continuous (Respirator) PREDICATE DEVICE The primary predicate device is the TBird Homecare Ventilator (K981971), manufactured by Bird Products Corp. of Palm Springs, CA. DESCRIPTION The LTV1000 ventilator is intended to provide continuous… | 1998 |
| † | K962517 | Model 7700 Quantum Pressure Support Ventilator PSV | 1997 |
| † | K811102 | Siemens-Elema AB Servo Ventilator 900 C | 1981 |
| † | K905244 | Model LP6 Ventilator, Modification | 1990 |
What descends from it? (40)
See all 407 later devices cite 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 |
| K083526 | Trilogy 100 Ventilator Class I | 2009 | 26 |
| K070594 | Palmtop Ventilator, Models PTV-8, PTV-10 Class I | 2007 | 12 |
| K082724 | Newport HTS50 Ventilator with Dual Pac Battery System | 2008 | 9 |
| K090888 | Newport HT70 Family of Ventilators Class I | 2009 | 2 |
| K034032 | PLV Continuum Ventilator, Model P2000 | 2004 | 1 |
| K072885 | Carina System, Model 8419350; Carina Basic Device, Model 5704110 Class I | 2008 | 0 |
Has anything in its family been recalled? (16 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Feb 22, 2008 | Not classified | Z-1463-2008 | Device Design | The failure of an electronic component could result in failure of the ventilator to breathe for the patient and/or failure of the ventilator to properly alarm to alert the caregiver. |
| Feb 22, 2008 | Not classified | Z-1469-2008 | Device Design | The failure of an electronic component could result in failure of the ventilator to breathe for the patient and/or failure of the ventilator to properly alarm to alert the caregiver. |
| Feb 22, 2008 | Not classified | Z-1468-2008 | Device Design | The failure of an electronic component could result in failure of the ventilator to breathe for the patient and/or failure of the ventilator to properly alarm to alert the caregiver. |
| Feb 22, 2008 | Not classified | Z-1467-2008 | Device Design | The failure of an electronic component could result in failure of the ventilator to breathe for the patient and/or failure of the ventilator to properly alarm to alert the caregiver. |
| Feb 22, 2008 | Not classified | Z-1464-2008 | Device Design | The failure of an electronic component could result in failure of the ventilator to breathe for the patient and/or failure of the ventilator to properly alarm to alert the caregiver. |
| Feb 22, 2008 | Not classified | Z-1470-2008 | Device Design | The failure of an electronic component could result in failure of the ventilator to breathe for the patient and/or failure of the ventilator to properly alarm to alert the caregiver. |
| Feb 22, 2008 | Not classified | Z-1466-2008 | Device Design | The failure of an electronic component could result in failure of the ventilator to breathe for the patient and/or failure of the ventilator to properly alarm to alert the caregiver. |
| Feb 22, 2008 | Not classified | Z-1465-2008 | Device Design | The failure of an electronic component could result in failure of the ventilator to breathe for the patient and/or failure of the ventilator to properly alarm to alert the caregiver. |
| Nov 9, 2005 | Not classified | Z-0184-06 | Other | Pulmonetic Systems has identified the potential of a printed circuit board malfunction, which can result in a ventilator malfunctio (e.g. Vent INOP, HW Fault, Xducer Fault) and possibly resulting in failure of the ventilator to breathe… |
| Nov 9, 2005 | Not classified | Z-0186-06 | Other | Pulmonetic Systems has identified the potential of a printed circuit board malfunction, which can result in a ventilator malfunctio (e.g. Vent INOP, HW Fault, Xducer Fault) and possibly resulting in failure of the ventilator to breathe… |
| Nov 9, 2005 | Not classified | Z-0185-06 | Other | Pulmonetic Systems has identified the potential of a printed circuit board malfunction, which can result in a ventilator malfunctio (e.g. Vent INOP, HW Fault, Xducer Fault) and possibly resulting in failure of the ventilator to breathe… |
| 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. |
The 5 latest of 12 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.
- K070594Palmtop Ventilator, Models PTV-8, PTV-10Pulmonetic Systems, Inc. · 2007 · Cites it directly · ◆ in the 2007 descendants bar of FIG. 12 Class I recalls
- K090888Newport HT70 Family of VentilatorsNewport Medical Instruments, Inc. · 2009 · Cites it directly · ◆ in the 2009 descendants bar of FIG. 13 Class I recalls
- K072885Carina System, Model 8419350; Carina Basic Device, Model 5704110Draeger Medical AG & Co. KG · 2008 · Cites it directly · ◆ in the 2008 descendants 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
- K162877VOCSN Unified Respiratory SystemVentec Life Systems, Inc. · 2017 · 2 generations on · ◆ in the 2017 descendants bar of FIG. 114 Class I recalls
- K162832731 Series VentilatorsZOLL Medical Corporation · 2017 · 2 generations on · ◆ in the 2017 descendants bar of FIG. 11 Class I recall
- 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
- K111146Newport HT70 VentilatorNewport Medical Instruments, Inc. · 2011 · 2 generations on · ◆ in the 2011 descendants bar of FIG. 14 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
Nearest 12 of 16 shown.
Nearest 5 of 16; all are on the web page.
What does this lineage say?
- The line of descent spans 15 years and passes through 3 companies; a new generation was cleared every 14.3 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K022750 (Respironics California, Inc., 2003) has gone furthest, with 29 descendants of its own.
- 1 other device also cites its predicate K981971.
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 LTV1000 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 10 kg (22 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, and transport settings.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K984056 · printed Nov 6, 2026
Cite this page
510(k) Report. “K984056: LTV 1000.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K984056
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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