510(k) · Cleared
Recalled · 2010Pulmonetic Systems LTV 1200 MR Conditional 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 Mar 18, 2009 as substantially equivalent to K073694 (Versamed Medical Systems, Inc., 2008) after a 96-day review. Its family tree reaches back 11 generations to 1991. 5 of the 62 devices in its family, counting itself, have a Class I recall. 2 later devices descend from it. It has been recalled once.
- Decided
- Mar 18, 2009
- Review
- 96 days
- Class
- Class II
- Product code
- CBK
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 11 generations to K902859 (1991). 59 ancestors in all, the oldest K883038 (1988). 2 later devices descend from it, 2 citing it directly. 5 of the 62 devices in this family, counting this one, have a Class I recall.
- Root · 11 generations backK902859 Servo Ventilator 300Siemens Life Support Systems · 1991 · Recalled
- 7 generations between
- 3 generations backK061627 Modification to I Vent 201Versamed Medical Systems, Inc. · 2006
- 2 generations backK063404 Servo-I Ventilator System, Models 64, 87 and 800Maquet Critical Care AB · 2007
- 1 generation backK073694 Ivent 2001 Mri ConditionalVersamed Medical Systems, Inc. · 2008
- This deviceK083688 Pulmonetic Systems LTV 1200 MR Conditional VentilatorPulmonetic Systems, Inc. · 2009
- Descendant · cites it directly · 0 of its ownK240807 VM-2000Ventis Medical, Inc. · 2024
- Descendant · cites it directly · 0 of its ownK202970 Ventway SparrowInovytech Medical Solutions, Ltd. · 2021
Show all 11 generations
- Root · 11 generations backK902859 Servo Ventilator 300Siemens Life Support Systems · 1991 · Recalled
- 10 generations backK960010 Servo Ventilator 300 Computer InterfaceSiemens Elema AB · 1996
- 9 generations backK970839 Servo Ventilator 300ASiemens Elema AB · 1997 · Recalled
- 8 generations backK992788 Bear Cub 750 PSVBear Medical Systems, Inc. · 1999
- 7 generations backK013642 AVEABird Products Corp. · 2002 · Recalled (Class I)
- 6 generations backK032451 Bird Tbird Vela VentilatorBird Products Corp. · 2004 · Recalled
- 5 generations backK052554 Modification to: Ivent 201 Portable VentilatorVersamed Medical Systems, Inc. · 2005
- 4 generations backK053270 IVENT 201Versamed Medical Systems, Inc. · 2006
- 3 generations backK061627 Modification to I Vent 201Versamed Medical Systems, Inc. · 2006
- 2 generations backK063404 Servo-I Ventilator System, Models 64, 87 and 800Maquet Critical Care AB · 2007
- 1 generation backK073694 Ivent 2001 Mri ConditionalVersamed Medical Systems, Inc. · 2008
- This deviceK083688 Pulmonetic Systems LTV 1200 MR Conditional VentilatorPulmonetic Systems, Inc. · 2009
Class I recalls in this family
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −11 | K902859 | Servo Ventilator 300 | Siemens Life Support Systems | 1991 | 3 |
| −10 | K960010 | Servo Ventilator 300 Computer Interface | Siemens Elema AB | 1996 | — |
| −9 | K970839 | Servo Ventilator 300A | Siemens Elema AB | 1997 | 4 |
| −8 | K992788 | Bear Cub 750 PSV | Bear Medical Systems, Inc. | 1999 | — |
| −7 | K013642 | AVEA | Bird Products Corp. | 2002 | Class I |
| −6 | K032451 | Bird Tbird Vela Ventilator | Bird Products Corp. | 2004 | 1 |
| −5 | K052554 | Modification to: Ivent 201 Portable Ventilator | Versamed Medical Systems, Inc. | 2005 | — |
| −4 | K053270 | IVENT 201 | Versamed Medical Systems, Inc. | 2006 | — |
| −3 | K061627 | Modification to I Vent 201 | Versamed Medical Systems, Inc. | 2006 | — |
| −2 | K063404 | Servo-I Ventilator System, Models 64, 87 and 800 | Maquet Critical Care AB | 2007 | — |
| −1 | K073694 | Ivent 2001 Mri Conditional | Versamed Medical Systems, Inc. | 2008 | — |
| 0 (this device) | K083688 | Pulmonetic Systems LTV 1200 MR Conditional Ventilator | Pulmonetic Systems, Inc. | 2009 | — |
| +1 | K240807 | VM-2000 | Ventis Medical, Inc. | 2024 | — |
| +1 | K202970 | Ventway Sparrow | Inovytech Medical Solutions, Ltd. | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1988 | 1 | 0 |
| 1990 | 5 | 0 |
| 1991 | 4 | 0 |
| 1992 | 2 | 0 |
| 1993 | 1 | 0 |
| 1994 | 2 | 0 |
| 1995 | 3 | 0 |
| 1996 | 2 | 0 |
| 1997 | 2 | 0 |
| 1998 | 7 | 2 |
| 1999 | 4 | 0 |
| 2000 | 3 | 1 |
| 2001 | 5 | 0 |
| 2002 | 2 | 0 |
| 2003 | 1 | 0 |
| 2004 | 3 | 1 |
| 2005 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 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.
5 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 |
|---|---|---|---|
| * | K073694 | Ivent 2001 Mri ConditionalSummary page 2…n listed is substantially equivalent to the predicate device(s) listed. Predicate Device 510(k) Clearance Manufacturer iVent 201 MR K073694 Versamed Corporation Conditional 2 Blue Hill Plaza Po… | 2008 |
What descends from it? (2)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (5 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jul 2, 2010 | Not classified | Z-2205-2010 | Process control | CareFusion is recalling the P/N 19189-001 Patient Circuit (SPU W/O PEEP 15ft) because some of the circuit sense lines may have been reversed during the manufacturing process. If the sense lines have been reversed, immediately upon… |
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.
- K041223Modification to Servo-I Ventilator System, Model 64 87 800 E407EMaquet Critical Care AB · 2004 · 3 generations back · ◆ in the 2004 ancestors bar of FIG. 11 Class I recall
- K013642AVEABird Products Corp. · 2002 · 5 generations back · ◆ on the line of descent in FIG. 113 Class I recalls
- K981072Esprit VentilatorRespironics, Inc. · 1998 · 5 generations back · ◆ in the 1998 ancestors bar of FIG. 11 Class I recall
- K001646Puritan-Bennett 840 Ventilator System with Neomode OptionPuritan Bennett Corp. · 2000 · 6 generations back · ◆ in the 2000 ancestors bar of FIG. 11 Class I recall
- K970460Nellcor Puritan Bennett, 840 Ventilator System (Model 840)Puritan Bennett Corp. · 1998 · 6 generations back · ◆ in the 1998 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 18 years and passes through 7 companies; a new generation was cleared every 1.3 years on median.
- 16 of the 59 ancestors have a recall of any class; 5 have a Class I recall.
- Of its descendants, K240807 (Ventis Medical, Inc., 2024) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K073694.
How does its category compare?
All CBK devicesCBK Ventilator, Continuous, Facility Use: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, 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?
The LTV® 1200 ventilator is intended to provide continuous or intermittent ventilatory support for the care of the 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 5kg (11 lbs.), who require the following types of ventilatory support…
Read the full statement (150 words)
The LTV® 1200 ventilator is intended to provide continuous or intermittent ventilatory support for the care of the 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 5kg (11 lbs.), who require the following types of ventilatory support:
· Positive Pressure Ventilation, delivered invasively (via endotrach tube or trach tube) or non-invasively (via mask or nasal prongs).
· Assist/Control, SIMV, CPAP, or NPPV modes of ventilation.
The ventilator is suitable for use in institutional, home, or transport settings.
The MR Conditional LTV® 1200 System is suitable for use in both 1.5 and 3.0 Tesla (not to exceed 3.0 Tesla static magnetic field) shielded magnetic scanners.
CAUTION: Federal law restricts this device to sale by or on the order of a physician.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K083688 · printed Nov 6, 2026
Cite this page
510(k) Report. “K083688: Pulmonetic Systems LTV 1200 MR Conditional Ventilator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K083688
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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