510(k) · Cleared
Recalled · Class I · 2025Newport HT70 Ventilator
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Newport Medical Instruments, Inc. · CBK Ventilator, Continuous, Facility Use
Cleared on Dec 1, 2011 as substantially equivalent to K090888 (Newport Medical Instruments, Inc., 2009) and 2 other predicates after a 223-day review. Its family tree reaches back 12 generations to 1991. 9 of the 85 devices in its family, counting itself, have a Class I recall. 1 later device descends from it. It has been recalled 4 times, including 4 Class I recalls.
- Decided
- Dec 1, 2011
- Review
- 223 days
- Class
- Class II
- Product code
- CBK
- Recalls
- 4 (4 Class I)
- Predicates
- 3
Its longest line of descent runs back 12 generations to K902859 (1991). 83 ancestors in all, the oldest K841279 (1984). 1 later device descends from it, 1 citing it directly. 9 of the 85 devices in this family, counting this one, have a Class I recall.
- Root · 12 generations backK902859 Servo Ventilator 300Siemens Life Support Systems · 1991 · Recalled
- 8 generations between
- 3 generations backK063404 Servo-I Ventilator System, Models 64, 87 and 800Maquet Critical Care AB · 2007
- 2 generations backK073694 Ivent 2001 Mri ConditionalVersamed Medical Systems, Inc. · 2008
- 1 generation backK090888 Newport HT70 Family of VentilatorsNewport Medical Instruments, Inc. · 2009 · Recalled (Class I)
- This deviceK111146 Newport HT70 VentilatorNewport Medical Instruments, Inc. · 2011
- Descendant · cites it directly · 0 of its ownK121891 Newport Aura VentilatorNewport Medical Instruments, Inc. · 2012
Show all 12 generations
- Root · 12 generations backK902859 Servo Ventilator 300Siemens Life Support Systems · 1991 · Recalled
- 11 generations backK960010 Servo Ventilator 300 Computer InterfaceSiemens Elema AB · 1996
- 10 generations backK970839 Servo Ventilator 300ASiemens Elema AB · 1997 · Recalled
- 9 generations backK992788 Bear Cub 750 PSVBear Medical Systems, Inc. · 1999
- 8 generations backK013642 AVEABird Products Corp. · 2002 · Recalled (Class I)
- 7 generations backK032451 Bird Tbird Vela VentilatorBird Products Corp. · 2004 · Recalled
- 6 generations backK052554 Modification to: Ivent 201 Portable VentilatorVersamed Medical Systems, Inc. · 2005
- 5 generations backK053270 IVENT 201Versamed Medical Systems, Inc. · 2006
- 4 generations backK061627 Modification to I Vent 201Versamed Medical Systems, Inc. · 2006
- 3 generations backK063404 Servo-I Ventilator System, Models 64, 87 and 800Maquet Critical Care AB · 2007
- 2 generations backK073694 Ivent 2001 Mri ConditionalVersamed Medical Systems, Inc. · 2008
- 1 generation backK090888 Newport HT70 Family of VentilatorsNewport Medical Instruments, Inc. · 2009 · Recalled (Class I)
- This deviceK111146 Newport HT70 VentilatorNewport Medical Instruments, Inc. · 2011
Class I recalls in this family
Most influential descendants
Showing 1 of 1 · See all- K121891Newport Aura VentilatorNewport Medical Instruments, Inc. · 2012 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −12 | K902859 | Servo Ventilator 300 | Siemens Life Support Systems | 1991 | 3 |
| −11 | K960010 | Servo Ventilator 300 Computer Interface | Siemens Elema AB | 1996 | — |
| −10 | K970839 | Servo Ventilator 300A | Siemens Elema AB | 1997 | 4 |
| −9 | K992788 | Bear Cub 750 PSV | Bear Medical Systems, Inc. | 1999 | — |
| −8 | K013642 | AVEA | Bird Products Corp. | 2002 | Class I |
| −7 | K032451 | Bird Tbird Vela Ventilator | Bird Products Corp. | 2004 | 1 |
| −6 | K052554 | Modification to: Ivent 201 Portable Ventilator | Versamed Medical Systems, Inc. | 2005 | — |
| −5 | K053270 | IVENT 201 | Versamed Medical Systems, Inc. | 2006 | — |
| −4 | K061627 | Modification to I Vent 201 | Versamed Medical Systems, Inc. | 2006 | — |
| −3 | K063404 | Servo-I Ventilator System, Models 64, 87 and 800 | Maquet Critical Care AB | 2007 | — |
| −2 | K073694 | Ivent 2001 Mri Conditional | Versamed Medical Systems, Inc. | 2008 | — |
| −1 | K090888 | Newport HT70 Family of Ventilators | Newport Medical Instruments, Inc. | 2009 | Class I |
| 0 (this device) | K111146 | Newport HT70 Ventilator | Newport Medical Instruments, Inc. | 2011 | — |
| +1 | K121891 | Newport Aura Ventilator | Newport Medical Instruments, Inc. | 2012 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1984 | 1 | 0 |
| 1988 | 1 | 0 |
| 1990 | 6 | 0 |
| 1991 | 4 | 0 |
| 1992 | 2 | 0 |
| 1993 | 1 | 0 |
| 1994 | 3 | 0 |
| 1995 | 3 | 0 |
| 1996 | 3 | 0 |
| 1997 | 3 | 0 |
| 1998 | 11 | 2 |
| 1999 | 6 | 0 |
| 2000 | 5 | 1 |
| 2001 | 6 | 0 |
| 2002 | 3 | 0 |
| 2003 | 3 | 1 |
| 2004 | 5 | 1 |
| 2005 | 2 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 1 |
| 2008 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 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.
9 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 |
|---|---|---|---|
| * | K090888 | Newport HT70 Family of VentilatorsSummary page 1…The HT7O is substantially equivalent to the following legally marketed predicate devices: * NEWPORT HT70® Ventilator cleared under K090888; * CareFusion LTV0 1200 cleared under K060647; * Versamed Medical Systems iVENTTM 201 cle… | 2009 |
| * | K060647 | LTV 1200 VentilatorSummary page 1…y marketed predicate devices: * NEWPORT HT70® Ventilator cleared under K090888; * CareFusion LTV0 1200 cleared under K060647; * Versamed Medical Systems iVENTTM 201 cleared under K073694. IV. Device Description… | 2006 |
| * | K073694 | Ivent 2001 Mri ConditionalSummary page 1…tilator cleared under K090888; * CareFusion LTV0 1200 cleared under K060647; * Versamed Medical Systems iVENTTM 201 cleared under K073694. IV. Device Description The Newport HT70 Ventilator provides ventilatory support for neonate, infant,… | 2008 |
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 |
|---|---|---|---|
| K121891 | Newport Aura Ventilator | 2012 | 0 |
Has anything in its family been recalled? (9 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| May 21, 2025 | Class I | Z-1915-2025 | Component design/selection | Ventilator Printed Circuit Board Assembly may have two separate capacitors that may fail, which may result in the ventilator either shutting down during use, thus necessitating use of an alternate form of ventilation, or the shutdown… |
| Mar 30, 2017 | Class I | Z-1874-2017 | Software in the Use Environment | Medtronic is issuing a voluntary field corrective action for all its Newport" HT70 and Newport" HT70 Plus ventilators because they may shutdown spontaneously during normal operation without an accompanying alarm. |
| Apr 5, 2013 | Class I | Z-1171-2013 | Component design/selection | Newport Medical Instruments is conducting a voluntary recall on certain Newport Medical Instruments HT70 and HT70 Plus ventilator Power Pac batteries due to customer reports of Newport HT70 and HT70 Plus ventilators alarming and going to… |
| Aug 3, 2012 | Class I | Z-2250-2012 | Nonconforming Material/Component | May emit a continuous high priority alarm and the ventilator may stop ventilating, due to a component failure on the control board. |
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 · Direct predicate · ◆ on the line of descent in FIG. 13 Class I recalls
- K070594Palmtop Ventilator, Models PTV-8, PTV-10Pulmonetic Systems, Inc. · 2007 · 2 generations back · ◆ in the 2007 ancestors bar of FIG. 12 Class I recalls
- 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 · 3 generations back · ◆ on the line of descent in FIG. 113 Class I recalls
- K023366Datex-Ohmeda 7900 Ventilator EnhancementsDatex-Ohmeda, Inc. · 2003 · 4 generations back · ◆ in the 2003 ancestors bar of FIG. 11 Class I recall
- K981072Esprit VentilatorRespironics, Inc. · 1998 · 4 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 · 4 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
Nearest 5 of 8; all are on the web page.
What does this lineage say?
- The line of descent spans 20 years and passes through 7 companies; a new generation was cleared every 1.5 years on median.
- 30 of the 83 ancestors have a recall of any class; 8 have a Class I recall.
- Of its descendants, K121891 (Newport Medical Instruments, Inc., 2012) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K090888.
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 Newport HT70 family of ventilators is intended to provide continuous or intermittent positive pressure mechanical ventilatory support for the care of individuals who require mechanical ventilation through invasive or non-invasive interfaces. Specifically, the Newport HT70 family of ventilators is applicable for infant, pediatric and adult patients greater than or equal to 5 kg (11 Ibs).
The Newport HT70 is a restricted medical device intended for use by qualified, trained personnel under the direction of a physician.
The Newport HT70 is suitable for use in hospital, sub-acute, emergency room, and home care environments, as well as for transport and emergency response applications.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K111146 · printed Nov 3, 2026
Cite this page
510(k) Report. “K111146: Newport HT70 Ventilator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K111146
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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