510(k) · Cleared
Recalled · Class I · 2014Palmtop Ventilator, Models PTV-8, PTV-10
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 Aug 1, 2007 as substantially equivalent to K060647 (Pulmonetic Systems, Inc., 2006) and 4 other predicates after a 152-day review. Its family tree reaches back 7 generations to 1991. 11 of the 68 devices in its family, counting itself, have a Class I recall. 12 later devices descend from it. It has been recalled 4 times, including 2 Class I recalls.
- Decided
- Aug 1, 2007
- Review
- 152 days
- Class
- Class II
- Product code
- CBK
- Recalls
- 4 (2 Class I)
- Predicates
- 5
Its longest line of descent runs back 7 generations to K902859 (1991). 55 ancestors in all, the oldest K841279 (1984). 12 later devices descend from it, 3 citing it directly. 11 of the 68 devices in this family, counting this one, have a Class I recall.
- Root · 7 generations backK902859 Servo Ventilator 300Siemens Life Support Systems · 1991 · Recalled
- 6 generations backK960010 Servo Ventilator 300 Computer InterfaceSiemens Elema AB · 1996
- 5 generations backK970839 Servo Ventilator 300ASiemens Elema AB · 1997 · Recalled
- 4 generations backK992788 Bear Cub 750 PSVBear Medical Systems, Inc. · 1999
- 3 generations backK013642 AVEABird Products Corp. · 2002 · Recalled (Class I)
- 2 generations backK022674 Bird Avea VentilatorBird Products Corp. · 2002 · Recalled
- 1 generation backK060647 LTV 1200 VentilatorPulmonetic Systems, Inc. · 2006
- This deviceK070594 Palmtop Ventilator, Models PTV-8, PTV-10Pulmonetic Systems, Inc. · 2007
- Descendant · cites it directly · 6 of its ownK162877 VOCSN Unified Respiratory SystemVentec Life Systems, Inc. · 2017 · Recalled (Class I)
- Descendant · 2 generations on · 5 of its ownK181166 Trilogy EvoRespironics, Inc. · 2019 · Recalled (Class I)
- Descendant · 3 generations on · 2 of its ownK193586 Vivo 45 LSBreas Medical AB · 2021 · Recalled (Class I)
- Descendant · cites it directly · 2 of its ownK090888 Newport HT70 Family of VentilatorsNewport Medical Instruments, Inc. · 2009 · Recalled (Class I)
- Descendant · cites it directly · 1 of its ownK162832 731 Series VentilatorsZOLL Medical Corporation · 2017 · Recalled (Class I)
Showing 5 of 12 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 12 · See all- K162877VOCSN Unified Respiratory SystemVentec Life Systems, Inc. · 2017 · cites it directly6descendants
- K181166Trilogy EvoRespironics, Inc. · 2019 · 2 generations on5descendants
- K193586Vivo 45 LSBreas Medical AB · 2021 · 3 generations on2descendants
- K090888Newport HT70 Family of VentilatorsNewport Medical Instruments, Inc. · 2009 · cites it directly2descendants
- K162832731 Series VentilatorsZOLL Medical Corporation · 2017 · cites it directly1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K902859 | Servo Ventilator 300 | Siemens Life Support Systems | 1991 | 3 |
| −6 | K960010 | Servo Ventilator 300 Computer Interface | Siemens Elema AB | 1996 | — |
| −5 | K970839 | Servo Ventilator 300A | Siemens Elema AB | 1997 | 4 |
| −4 | K992788 | Bear Cub 750 PSV | Bear Medical Systems, Inc. | 1999 | — |
| −3 | K013642 | AVEA | Bird Products Corp. | 2002 | Class I |
| −2 | K022674 | Bird Avea Ventilator | Bird Products Corp. | 2002 | 5 |
| −1 | K060647 | LTV 1200 Ventilator | Pulmonetic Systems, Inc. | 2006 | — |
| 0 (this device) | K070594 | Palmtop Ventilator, Models PTV-8, PTV-10 | Pulmonetic Systems, Inc. | 2007 | — |
| +1 | K162877 | VOCSN Unified Respiratory System | Ventec Life Systems, Inc. | 2017 | Class I |
| +2 | K181166 | Trilogy Evo | Respironics, Inc. | 2019 | Class I |
| +3 | K193586 | Vivo 45 LS | Breas Medical AB | 2021 | Class I |
| +1 | K090888 | Newport HT70 Family of Ventilators | Newport Medical Instruments, Inc. | 2009 | Class I |
| +1 | K162832 | 731 Series Ventilators | ZOLL Medical Corporation | 2017 | Class I |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1984 | 1 | 0 |
| 1988 | 1 | 0 |
| 1990 | 4 | 0 |
| 1991 | 4 | 0 |
| 1992 | 2 | 0 |
| 1993 | 1 | 0 |
| 1994 | 3 | 0 |
| 1995 | 3 | 0 |
| 1996 | 3 | 0 |
| 1997 | 2 | 0 |
| 1998 | 10 | 2 |
| 1999 | 5 | 0 |
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 3 | 1 |
| 2004 | 2 | 0 |
| 2005 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 1 |
| 2011 | 1 | 1 |
| 2012 | 1 | 0 |
| 2017 | 2 | 2 |
| 2019 | 1 | 1 |
| 2021 | 1 | 1 |
| 2024 | 3 | 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.
11 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? (5)
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 |
|---|---|---|---|
| * | K060647 | LTV 1200 VentilatorSummary page 3…ces are substantially equivalent to the predicate devices listed below. Predicate Device 510(k) Clearance Manufacturer LTV 1200 K060647 VIASYS Ventilator Healthcare/Pulmonetic… | 2006 |
| * | K981371 | LTV 1000 VentilatorSummary page 3…Suite 100 Minneapolis, MN 55447 LTV 1000 K981371 VIASYS Ventilator K984056 Healthcare/Pulmonetic… | 1998 |
| * | K984056 | LTV 1000Summary page 3…00 Minneapolis, MN 55447 LTV 1000 K981371 VIASYS Ventilator K984056 Healthcare/Pulmonetic Systems, Inc.… | 1999 |
| * | K021981 | Ivent 201 Portable VentilatorSummary page 3…Suite 100 Minneapolis, MN 55447 iVent 201 K021981 Versamed Corporation Portable 2 Blue Hill Plaza Ventila… | 2003 |
| * | K032451 | Bird Tbird Vela VentilatorSummary page 3…2 Blue Hill Plaza Ventilator with Pearl River, NY 10965 Pulse Oximeter TBird VELA K032451 VIASYS Healthcare/Bird Ventilator Products Corporation… | 2004 |
What descends from it? (12)
See all 123 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (11 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Aug 8, 2014 | Class I | Z-2593-2014 | Component design/selection | CareFusion has identified a potential for damage to the power connector on the EnVe and ReVel ventilators due to misconnection by the operator. The input port on the ventilators must have the adapters correctly aligned to function… |
| Jun 19, 2012 | Class I | Z-2006-2012 | Device Design | CareFusion identified that the EnVe Ventilator may not hold the set Positive End Expiratory Pressure (PEEP) value either intermittently or continuously or it may alarm for a Patient Circuit Fault. The unit will activate either a Low PEEP… |
| Sep 12, 2011 | Not classified | Z-0074-2012 | Device Design | CareFusion has identified potential risks associated with the EnVe ventilator manufactured between December 2010 and May 2011. There are 3 issues that can result in ventilation delivery to the patient being interrupted. CareFusion will be… |
| Jan 8, 2010 | Not classified | Z-0857-2010 | Component design/selection | CareFusion is recalling the EnVe Ventilator because the EnVe Ventilator does not fully meet applicable standards for immunity to electro-Magnetic Interference (EMI) when tested in the laboratory environment. CareFusion has identified… |
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.
- K013642AVEABird Products Corp. · 2002 · 2 generations back · ◆ on the line of descent in FIG. 113 Class I recalls
- K981072Esprit VentilatorRespironics, Inc. · 1998 · 2 generations back · ◆ in the 1998 ancestors bar of FIG. 11 Class I recall
- K970460Nellcor Puritan Bennett, 840 Ventilator System (Model 840)Puritan Bennett Corp. · 1998 · 3 generations back · ◆ in the 1998 ancestors bar of FIG. 11 Class I recall
- K023366Datex-Ohmeda 7900 Ventilator EnhancementsDatex-Ohmeda, Inc. · 2003 · 4 generations back · ◆ in the 2003 ancestors bar of FIG. 11 Class I recall
- K090888Newport HT70 Family of VentilatorsNewport Medical Instruments, Inc. · 2009 · Cites it directly · ◆ in the 2009 descendants bar of FIG. 13 Class I recalls
- K162877VOCSN Unified Respiratory SystemVentec Life Systems, Inc. · 2017 · Cites it directly · ◆ in the 2017 descendants bar of FIG. 114 Class I recalls
- K162832731 Series VentilatorsZOLL Medical Corporation · 2017 · Cites it directly · ◆ 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
- K181166Trilogy EvoRespironics, Inc. · 2019 · 2 generations on · ◆ in the 2019 descendants bar of FIG. 131 Class I recalls
- K193586Vivo 45 LSBreas Medical AB · 2021 · 3 generations on · ◆ in the 2021 descendants bar of FIG. 11 Class I recall
Nearest 5 of 10; all are on the web page.
What does this lineage say?
- The line of descent spans 16 years and passes through 5 companies; a new generation was cleared every 1.9 years on median.
- 16 of the 55 ancestors have a recall of any class; 4 have a Class I recall.
- Of its descendants, K162877 (Ventec Life Systems, Inc., 2017) has gone furthest, with 6 descendants of its own.
- 8 other devices also cite its predicate K060647.
How does its category compare?
All CBK devicesCBK Ventilator, Continuous, Facility Use: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.
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?
PALMTop PTV Models 8/10 are designed for use on patients who require respiratory support or mechanical ventilation and weigh a minimum of 5 kg (11 lbs). It is suitable for service in homecare, hospital and transport environments as a source of continuous or intermittent positive pressure ventilatory support, delivered invasively or non-invasively.
PALMTop Ventilators are restricted medical devices intended for operation by trained personnel under the direction of a physician and in accordance with all applicable state laws and regulations.
Federal law (USA) restricts the sale of this device except by or on the order of a physician.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K070594 · printed Nov 6, 2026
Cite this page
510(k) Report. “K070594: Palmtop Ventilator, Models PTV-8, PTV-10.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K070594
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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