510(k) · Cleared
ClearedModel LTV 1100 Ventilator
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Care Fusion · CBK Ventilator, Continuous, Facility Use
Cleared on Jan 26, 2011 as substantially equivalent to K060647 (Pulmonetic Systems, Inc., 2006) and 2 other predicates after a 230-day review. Its family tree reaches back 8 generations to 1991. 5 of the 53 devices in its family, counting itself, have a Class I recall. 1 later device descends from it.
- Decided
- Jan 26, 2011
- Review
- 230 days
- Class
- Class II
- Product code
- CBK
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 8 generations to K902859 (1991). 51 ancestors in all, the oldest K895541 (1990). 1 later device descends from it, 1 citing it directly. 5 of the 53 devices in this family, counting this one, have a Class I recall.
- Root · 8 generations backK902859 Servo Ventilator 300Siemens Life Support Systems · 1991 · Recalled
- 7 generations backK960010 Servo Ventilator 300 Computer InterfaceSiemens Elema AB · 1996
- 6 generations backK970839 Servo Ventilator 300ASiemens Elema AB · 1997 · Recalled
- 5 generations backK992788 Bear Cub 750 PSVBear Medical Systems, Inc. · 1999
- 4 generations backK013642 AVEABird Products Corp. · 2002 · Recalled (Class I)
- 3 generations backK022674 Bird Avea VentilatorBird Products Corp. · 2002 · Recalled
- 2 generations backK060647 LTV 1200 VentilatorPulmonetic Systems, Inc. · 2006
- 1 generation backK093094 Vela VentilatorCardinal Health 207, Inc. · 2010
- This deviceK101643 Model LTV 1100 VentilatorCare Fusion · 2011
- Descendant · cites it directly · 0 of its ownK201082 LTV2 Series VentilatorsVyaire Medical, Inc. · 2021
Class I recalls in this family
Most influential descendants
Showing 1 of 1 · See all- K201082LTV2 Series VentilatorsVyaire Medical, Inc. · 2021 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K902859 | Servo Ventilator 300 | Siemens Life Support Systems | 1991 | 3 |
| −7 | K960010 | Servo Ventilator 300 Computer Interface | Siemens Elema AB | 1996 | — |
| −6 | K970839 | Servo Ventilator 300A | Siemens Elema AB | 1997 | 4 |
| −5 | K992788 | Bear Cub 750 PSV | Bear Medical Systems, Inc. | 1999 | — |
| −4 | K013642 | AVEA | Bird Products Corp. | 2002 | Class I |
| −3 | K022674 | Bird Avea Ventilator | Bird Products Corp. | 2002 | 5 |
| −2 | K060647 | LTV 1200 Ventilator | Pulmonetic Systems, Inc. | 2006 | — |
| −1 | K093094 | Vela Ventilator | Cardinal Health 207, Inc. | 2010 | — |
| 0 (this device) | K101643 | Model LTV 1100 Ventilator | Care Fusion | 2011 | — |
| +1 | K201082 | LTV2 Series Ventilators | Vyaire Medical, Inc. | 2021 | — |
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 | 3 | 0 |
| 1998 | 8 | 1 |
| 1999 | 4 | 0 |
| 2000 | 3 | 1 |
| 2001 | 4 | 0 |
| 2002 | 1 | 0 |
| 2003 | 2 | 1 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2008 | 1 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 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? (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 |
|---|---|---|---|
| * | K060647 | LTV 1200 VentilatorSummary page 1…code CFR Section I Panel 73 CB3K 21 CFR 868.5895 1Anesthesiology] Predicate Device: LTV 1200 ventilator (K060647), Vela (K(093094), LTV800 (K(981371) Device Description: The LTVs 1100 ventilator is designed to provide the functionality in a… | 2006 |
| * | K093094 | Vela VentilatorSummary page 1…Section I Panel 73 CB3K 21 CFR 868.5895 1Anesthesiology] Predicate Device: LTV 1200 ventilator (K060647), Vela (K(093094), LTV800 (K(981371) Device Description: The LTVs 1100 ventilator is designed to provide the functionality in a small pac… | 2010 |
| * | K981371 | LTV 1000 VentilatorSummary page 1…I Panel 73 CB3K 21 CFR 868.5895 1Anesthesiology] Predicate Device: LTV 1200 ventilator (K060647), Vela (K(093094), LTV800 (K(981371) Device Description: The LTVs 1100 ventilator is designed to provide the functionality in a small package. The LW®e 1100… | 1998 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K201082 | LTV2 Series Ventilators | 2021 | 0 |
Has anything in its family been recalled? (5 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.
- K073069Modification to Avea VentilatorViasys Respiratory Care, Inc. · 2008 · 2 generations back · ◆ in the 2008 ancestors bar of FIG. 113 Class I recalls
- K013642AVEABird Products Corp. · 2002 · 3 generations back · ◆ on the line of descent in FIG. 113 Class I recalls
- K001646Puritan-Bennett 840 Ventilator System with Neomode OptionPuritan Bennett Corp. · 2000 · 3 generations back · ◆ in the 2000 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
- K970460Nellcor Puritan Bennett, 840 Ventilator System (Model 840)Puritan Bennett Corp. · 1998 · 4 generations back · ◆ in the 1998 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 20 years and passes through 7 companies; a new generation was cleared every 2.7 years on median.
- 19 of the 51 ancestors have a recall of any class; 5 have a Class I recall.
- Of its descendants, K201082 (Vyaire Medical, Inc., 2021) has gone furthest, with 0 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. 2011, 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 LW® 1100 ventilator is intended to provide continuous or intermittent ventilatory support for the care of the individuals who require mechanical ventilation. The ventilator is a medical device intended for use by qualified, trained personnel under the direction of a physician. Specifically, the ventilator isapplicable for adult and pediatric patients weighing at least 5kg (11 lbs.), who require the following types of ventilatory support: Positive…
Read the full statement (102 words)
The LW® 1100 ventilator is intended to provide continuous or intermittent ventilatory support for the care of the individuals who require mechanical ventilation. The ventilator is a medical device intended for use by qualified, trained personnel under the direction of a physician. Specifically, the ventilator isapplicable 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 endlotrach tube or trach tube) or non-invasively (via mask or nasal prongs).
Assist/Control, SIMV, CPAP, and NPPV modes of ventilation.
The ventilator issuitable for use in institutional, home, or transport settings.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K101643 · printed Nov 3, 2026
Cite this page
510(k) Report. “K101643: Model LTV 1100 Ventilator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K101643
Report an extraction error
Are you the manufacturer?
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