510(k) · Cleared
ClearedLTV 1200 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 May 25, 2006 as substantially equivalent to K011957 (Versamed, Ltd., 2001) and 2 other predicates after a 73-day review. Its family tree reaches back 6 generations to 1991. 16 of the 66 devices in its family, counting itself, have a Class I recall. 29 later devices descend from it.
- Decided
- May 25, 2006
- Review
- 73 days
- Class
- Class II
- Product code
- CBK
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 6 generations to K902859 (1991). 36 ancestors in all, the oldest K895541 (1990). 29 later devices descend from it, 9 citing it directly. 16 of the 66 devices in this family, counting this one, have a Class I recall.
- Root · 6 generations backK902859 Servo Ventilator 300Siemens Life Support Systems · 1991 · Recalled
- 5 generations backK960010 Servo Ventilator 300 Computer InterfaceSiemens Elema AB · 1996
- 4 generations backK970839 Servo Ventilator 300ASiemens Elema AB · 1997 · Recalled
- 3 generations backK992788 Bear Cub 750 PSVBear Medical Systems, Inc. · 1999
- 2 generations backK013642 AVEABird Products Corp. · 2002 · Recalled (Class I)
- 1 generation backK022674 Bird Avea VentilatorBird Products Corp. · 2002 · Recalled
- This deviceK060647 LTV 1200 VentilatorPulmonetic Systems, Inc. · 2006
- Descendant · cites it directly · 12 of its ownK070594 Palmtop Ventilator, Models PTV-8, PTV-10Pulmonetic Systems, Inc. · 2007 · Recalled (Class I)
- Descendant · cites it directly · 10 of its ownK133868 Astral VentilatorResmed, Ltd. · 2014 · Recalled
- Descendant · 2 generations on · 7 of its ownK160481 Vivo 60Breas Medical AB · 2016 · Recalled
- Descendant · 2 generations on · 6 of its ownK162877 VOCSN Unified Respiratory SystemVentec Life Systems, Inc. · 2017 · Recalled (Class I)
- Descendant · cites it directly · 6 of its ownK091238 Uni-Vent-731 Series Ventilators, Model 731EMV+Impact Instrumentation, Inc. · 2009 · Recalled
Showing 5 of 29 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 29 · See all- K070594Palmtop Ventilator, Models PTV-8, PTV-10Pulmonetic Systems, Inc. · 2007 · cites it directly12descendants
- K133868Astral VentilatorResmed, Ltd. · 2014 · cites it directly10descendants
- K160481Vivo 60Breas Medical AB · 2016 · 2 generations on7descendants
- K162877VOCSN Unified Respiratory SystemVentec Life Systems, Inc. · 2017 · 2 generations on6descendants
- K091238Uni-Vent-731 Series Ventilators, Model 731EMV+Impact Instrumentation, Inc. · 2009 · cites it directly6descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K902859 | Servo Ventilator 300 | Siemens Life Support Systems | 1991 | 3 |
| −5 | K960010 | Servo Ventilator 300 Computer Interface | Siemens Elema AB | 1996 | — |
| −4 | K970839 | Servo Ventilator 300A | Siemens Elema AB | 1997 | 4 |
| −3 | K992788 | Bear Cub 750 PSV | Bear Medical Systems, Inc. | 1999 | — |
| −2 | K013642 | AVEA | Bird Products Corp. | 2002 | Class I |
| −1 | K022674 | Bird Avea Ventilator | Bird Products Corp. | 2002 | 5 |
| 0 (this device) | K060647 | LTV 1200 Ventilator | Pulmonetic Systems, Inc. | 2006 | — |
| +1 | K070594 | Palmtop Ventilator, Models PTV-8, PTV-10 | Pulmonetic Systems, Inc. | 2007 | Class I |
| +1 | K133868 | Astral Ventilator | Resmed, Ltd. | 2014 | 2 |
| +2 | K160481 | Vivo 60 | Breas Medical AB | 2016 | 2 |
| +2 | K162877 | VOCSN Unified Respiratory System | Ventec Life Systems, Inc. | 2017 | Class I |
| +1 | K091238 | Uni-Vent-731 Series Ventilators, Model 731EMV+ | Impact Instrumentation, Inc. | 2009 | 1 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 3 | 0 |
| 1991 | 1 | 0 |
| 1992 | 2 | 0 |
| 1994 | 3 | 0 |
| 1995 | 3 | 0 |
| 1996 | 3 | 0 |
| 1997 | 1 | 0 |
| 1998 | 5 | 1 |
| 1999 | 3 | 0 |
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
| 2003 | 2 | 1 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 1 |
| 2009 | 3 | 1 |
| 2010 | 1 | 0 |
| 2011 | 3 | 1 |
| 2012 | 2 | 1 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 3 | 2 |
| 2017 | 3 | 3 |
| 2018 | 1 | 1 |
| 2019 | 2 | 2 |
| 2021 | 2 | 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.
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? (3)
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 |
|---|---|---|---|
| * | K011957 | Ivent 201 Portable VentilatorSummary page 2…listed is substantially equivalent to the predicate device(s) listed. Predicate Device 510(k) Clearance Manufacturer iVent 201 Portable K01 1957 Versamed Corporation Ventilator 2 Blue Hill Plaza… | 2001 |
| * | K022674 | Bird Avea VentilatorSummary page 2…2 Blue Hill Plaza Pearl River, NY 10965 AVEA Ventilator K022674 Bird Products Corporation 1100 Bird Cent… | 2002 |
| * | K051767 | LTV 1000 VentilatorSummary page 2…1100 Bird Center Drive Palm Springs, CA 92262 LTV 1000 Ventilator K051767 Pulmonetic Systems, Inc. 17400 Medi… | 2005 |
What descends from it? (29)
See all 299 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K070594 | Palmtop Ventilator, Models PTV-8, PTV-10 Class I | 2007 | 12 |
| K133868 | Astral Ventilator | 2014 | 10 |
| K091238 | Uni-Vent-731 Series Ventilators, Model 731EMV+ | 2009 | 6 |
| K093094 | Vela Ventilator | 2010 | 2 |
| K141943 | Breathe Technologies LIFE2000 Ventilation System | 2015 | 1 |
| K111146 | Newport HT70 Ventilator Class I | 2011 | 1 |
| K101643 | Model LTV 1100 Ventilator | 2011 | 1 |
| K201082 | LTV2 Series Ventilators | 2021 | 0 |
| K081845 | IVENT101 | 2009 | 0 |
Has anything in its family been recalled? (16 Class I)
No FDA recall names this device.
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
- K023366Datex-Ohmeda 7900 Ventilator EnhancementsDatex-Ohmeda, Inc. · 2003 · 3 generations back · ◆ in the 2003 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
- K070594Palmtop Ventilator, Models PTV-8, PTV-10Pulmonetic Systems, Inc. · 2007 · Cites it directly · ◆ in the 2007 descendants bar of FIG. 12 Class I recalls
- K111146Newport HT70 VentilatorNewport Medical Instruments, Inc. · 2011 · Cites it directly · ◆ in the 2011 descendants bar of FIG. 14 Class I recalls
- K090888Newport HT70 Family of VentilatorsNewport Medical Instruments, Inc. · 2009 · 2 generations on · ◆ in the 2009 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
- K152068Astral 100/150Resmed, Ltd. · 2016 · 2 generations on · ◆ in the 2016 descendants bar of FIG. 11 Class I recall
- K170037Breathe Technologies Life2000™ Ventilation SystemBreathe Technologies · 2017 · 2 generations on · ◆ in the 2017 descendants bar of FIG. 112 Class I recalls
- K111473Uni-Vent (R) Model 731 Series Portable Critical Care VentilatorImpact Instrumentation, Inc. · 2012 · 3 generations on · ◆ in the 2012 descendants bar of FIG. 11 Class I recall
- K172875Astral 100/150Resmed, Ltd. · 2018 · 3 generations on · ◆ in the 2018 descendants bar of FIG. 12 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 5 companies; a new generation was cleared every 2.7 years on median.
- 12 of the 36 ancestors have a recall of any class; 3 have a Class I recall.
- Of its descendants, K070594 (Pulmonetic Systems, Inc., 2007) has gone furthest, with 12 descendants of its own.
- 3 other devices also cite its predicate K011957.
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 1200 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, CPAP, or NPPV 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/K060647 · printed Nov 4, 2026
Cite this page
510(k) Report. “K060647: LTV 1200 Ventilator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K060647
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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