510(k) · Cleared
Recalled · 2008LTV 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 30, 1998 as substantially equivalent to K950484 (Bird Products Corp., 1996) after a 197-day review. Its family tree reaches back 1 generation to 1996. 21 of the 67 devices in its family, counting itself, have a Class I recall. 65 later devices descend from it. It has been recalled 12 times.
- Decided
- Oct 30, 1998
- Review
- 197 days
- Class
- Class II
- Product code
- CBK
- Recalls
- 12
- Predicates
- 1
Its longest line of descent runs back 1 generation to K950484 (1996). 65 later devices descend from it, 6 citing it directly. 21 of the 67 devices in this family, counting this one, have a Class I recall.
- Root · 1 generation backK950484 Tbird VS Ventilator and Tbird Avs VentilatorBird Products Corp. · 1996
- This deviceK981371 LTV 1000 VentilatorPulmonetic Systems, Inc. · 1998
- Descendant · cites it directly · 44 of its ownK040790 Modification to LTV 1000 Ventilator/Breathing CircuitsPulmonetic Systems, Inc. · 2004
- Descendant · 2 generations on · 22 of its ownK060705 Carina HomeDraeger Medical B.V. · 2006 · Recalled
- Descendant · 3 generations on · 20 of its ownK103167 Stellar 150Resmed Germany, Inc. · 2011
- Descendant · 2 generations on · 20 of its ownK062267 Oxylog 3000Drager Medical B.V. · 2006 · Recalled (Class I)
- Descendant · 3 generations on · 13 of its ownK112006 Hamilton-TC1Hamilton Medical AG · 2012
Showing 5 of 65 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 65 · See all- K040790Modification to LTV 1000 Ventilator/Breathing CircuitsPulmonetic Systems, Inc. · 2004 · cites it directly44descendants
- K060705Carina HomeDraeger Medical B.V. · 2006 · 2 generations on22descendants
- K103167Stellar 150Resmed Germany, Inc. · 2011 · 3 generations on20descendants
- K062267Oxylog 3000Drager Medical B.V. · 2006 · 2 generations on20descendants
- K112006Hamilton-TC1Hamilton Medical AG · 2012 · 3 generations on13descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K950484 | Tbird VS Ventilator and Tbird Avs Ventilator | Bird Products Corp. | 1996 | — |
| 0 (this device) | K981371 | LTV 1000 Ventilator | Pulmonetic Systems, Inc. | 1998 | — |
| +1 | K040790 | Modification to LTV 1000 Ventilator/Breathing Circuits | Pulmonetic Systems, Inc. | 2004 | — |
| +2 | K060705 | Carina Home | Draeger Medical B.V. | 2006 | 1 |
| +3 | K103167 | Stellar 150 | Resmed Germany, Inc. | 2011 | — |
| +2 | K062267 | Oxylog 3000 | Drager Medical B.V. | 2006 | Class I |
| +3 | K112006 | Hamilton-TC1 | Hamilton Medical AG | 2012 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2006 | 2 | 1 |
| 2007 | 1 | 1 |
| 2008 | 3 | 2 |
| 2009 | 2 | 1 |
| 2010 | 3 | 0 |
| 2011 | 7 | 2 |
| 2012 | 12 | 4 |
| 2013 | 2 | 1 |
| 2014 | 3 | 0 |
| 2015 | 2 | 1 |
| 2016 | 5 | 1 |
| 2017 | 4 | 2 |
| 2019 | 3 | 2 |
| 2020 | 1 | 1 |
| 2021 | 3 | 2 |
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 4 | 0 |
| 2025 | 2 | 0 |
| 2026 | 3 | 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.
21 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 |
|---|---|---|---|
| * | K950484 | Tbird VS Ventilator and Tbird Avs VentilatorSummary page 1…de Name: LTV 1000 Common Name Ventilator Classification Name: Ventilator, Continuous (Respirator) PREDICATE DEVICE The primary predicate device is the TBird Ventilator (K950484), manufactured by Bird Products Corp. of Palm Springs, CA. DESCRIPTION The LTV 1000 ventilator is intended to provide continuou… | 1996 |
| † | 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? (65)
See all 656 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K040790 | Modification to LTV 1000 Ventilator/Breathing Circuits | 2004 | 44 |
| K070594 | Palmtop Ventilator, Models PTV-8, PTV-10 Class I | 2007 | 12 |
| K082724 | Newport HTS50 Ventilator with Dual Pac Battery System | 2008 | 9 |
| K082982 | Breathe Technologies Ventilator and Accessories | 2009 | 5 |
| K090888 | Newport HT70 Family of Ventilators Class I | 2009 | 2 |
| K101643 | Model LTV 1100 Ventilator | 2011 | 1 |
Has anything in its family been recalled? (21 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
- K062267Oxylog 3000Drager Medical B.V. · 2006 · 2 generations on · ◆ in the 2006 descendants bar of FIG. 13 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
- K111146Newport HT70 VentilatorNewport Medical Instruments, Inc. · 2011 · 2 generations on · ◆ in the 2011 descendants bar of FIG. 14 Class I recalls
- K072885Carina System, Model 8419350; Carina Basic Device, Model 5704110Draeger Medical AG & Co. KG · 2008 · 3 generations on · ◆ in the 2008 descendants bar of FIG. 11 Class I recall
- K082600Oxylog 2000 Plus System (Model 5705080), Oxylog 2000 Plus Basic Device (Model 5705082)Draeger Medical B.V. · 2008 · 3 generations on · ◆ in the 2008 descendants bar of FIG. 12 Class I recalls
- K103625Oxylog 3000 Plus Workstation, Oxylog 3000 Plus Basic DeviceDraeger Medical Systems, Inc. · 2011 · 3 generations on · ◆ in the 2011 descendants bar of FIG. 14 Class I recalls
- K141595O-Two E700,O-Two E600,O-Two E500O-Two Medical Technologies, Inc. · 2015 · 3 generations on · ◆ in the 2015 descendants bar of FIG. 13 Class I recalls
- K181166Trilogy EvoRespironics, Inc. · 2019 · 3 generations on · ◆ in the 2019 descendants bar of FIG. 131 Class I recalls
- K113053Bipap a 30 Ventilatory Support SystemRespironics, Inc. · 2012 · 4 generations on · ◆ in the 2012 descendants bar of FIG. 15 Class I recalls
Nearest 12 of 21 shown.
Nearest 5 of 21; all are on the web page.
What does this lineage say?
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 1bs), 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 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/K981371 · printed Nov 6, 2026
Cite this page
510(k) Report. “K981371: 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/K981371
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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