510(k) · Cleared
Recalled · 2008Modification to LTV 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 Apr 29, 2004 as substantially equivalent to K032226 (Pulmonetic Systems, Inc., 2003) and 1 other predicate after a 58-day review. Its family tree reaches back 2 generations to 1984. 2 of the 16 devices in its family, counting itself, have a Class I recall. 10 later devices descend from it. It has been recalled 8 times.
- Decided
- Apr 29, 2004
- Review
- 58 days
- Class
- Class II
- Product code
- CBK
- Recalls
- 8
- Predicates
- 2
Its longest line of descent runs back 2 generations to K841279 (1984). 5 ancestors in all. 10 later devices descend from it, 2 citing it directly. 2 of the 16 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 deviceK040540 Modification to LTV 1000 VentilatorPulmonetic Systems, Inc. · 2004
- Descendant · cites it directly · 9 of its ownK082724 Newport HTS50 Ventilator with Dual Pac Battery SystemNewport Medical Instruments, Inc. · 2008 · Recalled
- Descendant · 2 generations on · 5 of its ownK100753 Flight 60 Ventilator, Model F-60Flight Medical, Ltd. · 2010
- Descendant · 3 generations on · 4 of its ownK111683 Flight 60 VentilatorFlight Medical Innovations, Ltd. · 2011
- Descendant · 4 generations on · 3 of its ownK120726 Flight 60 VentilatorFlight Medical Innovations, Ltd. · 2012
- Descendant · 5 generations on · 2 of its ownK130171 Flight 60 VentilatorFlight Medical Innovations, Ltd. · 2014
Showing 5 of 10 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 10 · See all- K082724Newport HTS50 Ventilator with Dual Pac Battery SystemNewport Medical Instruments, Inc. · 2008 · cites it directly9descendants
- K100753Flight 60 Ventilator, Model F-60Flight Medical, Ltd. · 2010 · 2 generations on5descendants
- K111683Flight 60 VentilatorFlight Medical Innovations, Ltd. · 2011 · 3 generations on4descendants
- K120726Flight 60 VentilatorFlight Medical Innovations, Ltd. · 2012 · 4 generations on3descendants
- K130171Flight 60 VentilatorFlight Medical Innovations, Ltd. · 2014 · 5 generations on2descendants
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) | K040540 | Modification to LTV 1000 Ventilator | Pulmonetic Systems, Inc. | 2004 | — |
| +1 | K082724 | Newport HTS50 Ventilator with Dual Pac Battery System | Newport Medical Instruments, Inc. | 2008 | 2 |
| +2 | K100753 | Flight 60 Ventilator, Model F-60 | Flight Medical, Ltd. | 2010 | — |
| +3 | K111683 | Flight 60 Ventilator | Flight Medical Innovations, Ltd. | 2011 | — |
| +4 | K120726 | Flight 60 Ventilator | Flight Medical Innovations, Ltd. | 2012 | — |
| +5 | K130171 | Flight 60 Ventilator | Flight Medical Innovations, Ltd. | 2014 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 1 | 0 |
| 1996 | 1 | 0 |
| 2003 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2009 | 1 | 1 |
| 2010 | 1 | 0 |
| 2011 | 2 | 1 |
| 2012 | 2 | 0 |
| 2014 | 1 | 0 |
| 2016 | 1 | 0 |
| 2024 | 1 | 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.
2 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? (2)
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 |
|---|---|---|---|
| * | K032226 | LTV-1000 VentilatorSummary page 2…K984056 - Homecare settings. K002881 - Enhancements. K010608 - Lap Top Monitor. K032226 - 5 kg Patient Application. T-Bird AVS K981971 Bird Products, Palm… | 2003 |
| * | K981971 | Tbird VS/Avs Volume Ventilator, Models 15568, 15570 , LP10 Volume Ventilator with…Summary page 2…K002881 - Enhancements. K010608 - Lap Top Monitor. K032226 - 5 kg Patient Application. T-Bird AVS K981971 Bird Products, Palm Spring… | 1998 |
What descends from it? (10)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (2 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. |
The 5 latest of 8 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.
- K090888Newport HT70 Family of VentilatorsNewport Medical Instruments, Inc. · 2009 · Cites it directly · ◆ in the 2009 descendants bar of FIG. 13 Class I recalls
- K111146Newport HT70 VentilatorNewport Medical Instruments, Inc. · 2011 · 2 generations on · ◆ in the 2011 descendants bar of FIG. 14 Class I recalls
What does this lineage say?
- The line of descent spans 20 years and passes through 3 companies; a new generation was cleared every 14.3 years on median.
- 1 of the 5 ancestors has a recall of any class.
- Of its descendants, K082724 (Newport Medical Instruments, Inc., 2008) has gone furthest, with 9 descendants of its own.
- 3 other devices also cite its predicate K032226.
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 lbs.), 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 summary.
https://510kreport.com/device/K040540 · printed Nov 4, 2026
Cite this page
510(k) Report. “K040540: Modification to LTV 1000 Ventilator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K040540
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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