510(k) · Cleared
Recalled · 2005Modification to Lap Top Ventilator (LTV)
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 Mar 20, 2001 after a 19-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 2 of the 11 devices in its family, counting itself, have a Class I recall. 10 later devices descend from it. It has been recalled 4 times.
- Decided
- Mar 20, 2001
- Review
- 19 days
- Class
- Class II
- Product code
- CBK
- Recalls
- 4
- Predicates
- 0
10 later devices descend from it, 2 citing it directly. 2 of the 11 devices in this family, counting this one, have a Class I recall.
- This deviceK010608 Modification to Lap Top Ventilator (LTV)Pulmonetic Systems, Inc. · 2001
- 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 |
|---|---|---|---|---|---|
| 0 (this device) | K010608 | Modification to Lap Top Ventilator (LTV) | Pulmonetic Systems, Inc. | 2001 | — |
| +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 | — |
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), 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
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 |
|---|---|---|---|---|
| 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. |
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?
- Of its descendants, K082724 (Newport Medical Instruments, Inc., 2008) has gone furthest, with 9 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/K010608 · printed Nov 6, 2026
Cite this page
510(k) Report. “K010608: Modification to Lap Top Ventilator (LTV).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K010608
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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