510(k) · Cleared
Recalled · 2011Newport HTS50 Ventilator with Dual Pac Battery System
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 16, 2008 as substantially equivalent to K992133 (Newport Medical Instruments, Inc., 2000) and 14 other predicates after a 90-day review. Its family tree reaches back 9 generations to 1991. 6 of the 71 devices in its family, counting itself, have a Class I recall. 9 later devices descend from it. It has been recalled 2 times.
- Decided
- Dec 16, 2008
- Review
- 90 days
- Class
- Class II
- Product code
- CBK
- Recalls
- 2
- Predicates
- 15
Its longest line of descent runs back 9 generations to K902859 (1991). 61 ancestors in all, the oldest K841279 (1984). 9 later devices descend from it, 2 citing it directly. 6 of the 71 devices in this family, counting this one, have a Class I recall.
- Root · 9 generations backK902859 Servo Ventilator 300Siemens Life Support Systems · 1991 · Recalled
- 5 generations between
- 3 generations backK052554 Modification to: Ivent 201 Portable VentilatorVersamed Medical Systems, Inc. · 2005
- 2 generations backK053270 IVENT 201Versamed Medical Systems, Inc. · 2006
- 1 generation backK061627 Modification to I Vent 201Versamed Medical Systems, Inc. · 2006
- This deviceK082724 Newport HTS50 Ventilator with Dual Pac Battery SystemNewport Medical Instruments, Inc. · 2008
- Descendant · cites it directly · 5 of its ownK100753 Flight 60 Ventilator, Model F-60Flight Medical, Ltd. · 2010
- Descendant · 2 generations on · 4 of its ownK111683 Flight 60 VentilatorFlight Medical Innovations, Ltd. · 2011
- Descendant · 3 generations on · 3 of its ownK120726 Flight 60 VentilatorFlight Medical Innovations, Ltd. · 2012
- Descendant · 4 generations on · 2 of its ownK130171 Flight 60 VentilatorFlight Medical Innovations, Ltd. · 2014
- Descendant · cites it directly · 2 of its ownK090888 Newport HT70 Family of VentilatorsNewport Medical Instruments, Inc. · 2009 · Recalled (Class I)
Show all 9 generations
- Root · 9 generations backK902859 Servo Ventilator 300Siemens Life Support Systems · 1991 · Recalled
- 8 generations backK960010 Servo Ventilator 300 Computer InterfaceSiemens Elema AB · 1996
- 7 generations backK970839 Servo Ventilator 300ASiemens Elema AB · 1997 · Recalled
- 6 generations backK992788 Bear Cub 750 PSVBear Medical Systems, Inc. · 1999
- 5 generations backK013642 AVEABird Products Corp. · 2002 · Recalled (Class I)
- 4 generations backK032451 Bird Tbird Vela VentilatorBird Products Corp. · 2004 · Recalled
- 3 generations backK052554 Modification to: Ivent 201 Portable VentilatorVersamed Medical Systems, Inc. · 2005
- 2 generations backK053270 IVENT 201Versamed Medical Systems, Inc. · 2006
- 1 generation backK061627 Modification to I Vent 201Versamed Medical Systems, Inc. · 2006
- This deviceK082724 Newport HTS50 Ventilator with Dual Pac Battery SystemNewport Medical Instruments, Inc. · 2008
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 9 · See all- K100753Flight 60 Ventilator, Model F-60Flight Medical, Ltd. · 2010 · cites it directly5descendants
- K111683Flight 60 VentilatorFlight Medical Innovations, Ltd. · 2011 · 2 generations on4descendants
- K120726Flight 60 VentilatorFlight Medical Innovations, Ltd. · 2012 · 3 generations on3descendants
- K130171Flight 60 VentilatorFlight Medical Innovations, Ltd. · 2014 · 4 generations on2descendants
- K090888Newport HT70 Family of VentilatorsNewport Medical Instruments, Inc. · 2009 · cites it directly2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K902859 | Servo Ventilator 300 | Siemens Life Support Systems | 1991 | 3 |
| −8 | K960010 | Servo Ventilator 300 Computer Interface | Siemens Elema AB | 1996 | — |
| −7 | K970839 | Servo Ventilator 300A | Siemens Elema AB | 1997 | 4 |
| −6 | K992788 | Bear Cub 750 PSV | Bear Medical Systems, Inc. | 1999 | — |
| −5 | K013642 | AVEA | Bird Products Corp. | 2002 | Class I |
| −4 | K032451 | Bird Tbird Vela Ventilator | Bird Products Corp. | 2004 | 1 |
| −3 | K052554 | Modification to: Ivent 201 Portable Ventilator | Versamed Medical Systems, Inc. | 2005 | — |
| −2 | K053270 | IVENT 201 | Versamed Medical Systems, Inc. | 2006 | — |
| −1 | K061627 | Modification to I Vent 201 | Versamed Medical Systems, Inc. | 2006 | — |
| 0 (this device) | K082724 | Newport HTS50 Ventilator with Dual Pac Battery System | Newport Medical Instruments, Inc. | 2008 | — |
| +1 | K100753 | Flight 60 Ventilator, Model F-60 | Flight Medical, Ltd. | 2010 | — |
| +2 | K111683 | Flight 60 Ventilator | Flight Medical Innovations, Ltd. | 2011 | — |
| +3 | K120726 | Flight 60 Ventilator | Flight Medical Innovations, Ltd. | 2012 | — |
| +4 | K130171 | Flight 60 Ventilator | Flight Medical Innovations, Ltd. | 2014 | — |
| +1 | K090888 | Newport HT70 Family of Ventilators | Newport Medical Instruments, Inc. | 2009 | 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 | 3 | 0 |
| 2001 | 2 | 0 |
| 2002 | 1 | 0 |
| 2003 | 3 | 1 |
| 2004 | 3 | 0 |
| 2005 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 1 |
| 2010 | 1 | 0 |
| 2011 | 2 | 1 |
| 2012 | 2 | 0 |
| 2014 | 1 | 0 |
| 2016 | 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.
6 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? (15)
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 |
|---|---|---|---|
| * | K992133 | Newport HT50 Ventilator with Humidifier HT50-H, Newport HT50 Ventilator Without…Summary page 1…868.5895 III. Predicate Device The predicate devices for modified NEWPORT HT50 Ventilator are: · NEWPORT HT50 Ventilator cleared under K992133; · Pulmonetic Systems LTV 1000 cleared under K981371, K984056, K002881, K010608, K032226, K040540, an… | 2000 |
| * | K981371 | LTV 1000 VentilatorSummary page 1…te devices for modified NEWPORT HT50 Ventilator are: · NEWPORT HT50 Ventilator cleared under K992133; · Pulmonetic Systems LTV 1000 cleared under K981371, K984056, K002881, K010608, K032226, K040540, and K051767); and · Versamed Medical Systems IVENT201 c… | 1998 |
| * | K984056 | LTV 1000Summary page 1…s for modified NEWPORT HT50 Ventilator are: · NEWPORT HT50 Ventilator cleared under K992133; · Pulmonetic Systems LTV 1000 cleared under K981371, K984056, K002881, K010608, K032226, K040540, and K051767); and · Versamed Medical Systems IVENT201 cleared un… | 1999 |
| * | K002881 | Ventilator, Continuous (Respirator), Model LTV 1000Summary page 1…ified NEWPORT HT50 Ventilator are: · NEWPORT HT50 Ventilator cleared under K992133; · Pulmonetic Systems LTV 1000 cleared under K981371, K984056, K002881, K010608, K032226, K040540, and K051767); and · Versamed Medical Systems IVENT201 cleared under K9816… | 2000 |
| * | K010608 | Modification to Lap Top Ventilator (LTV)Summary page 1…ator are: · NEWPORT HT50 Ventilator cleared under K992133; · Pulmonetic Systems LTV 1000 cleared under K981371, K984056, K002881, K010608, K032226, K040540, and K051767); and · Versamed Medical Systems IVENT201 cleared under K981668, K01 1957,… | 2001 |
| * | K032226 | LTV-1000 VentilatorSummary page 1…· NEWPORT HT50 Ventilator cleared under K992133; · Pulmonetic Systems LTV 1000 cleared under K981371, K984056, K002881, K010608, K032226, K040540, and K051767); and · Versamed Medical Systems IVENT201 cleared under K981668, K01 1957, K021… | 2003 |
| * | K040540 | Modification to LTV 1000 VentilatorSummary page 1…· NEWPORT HT50 Ventilator cleared under K992133; · Pulmonetic Systems LTV 1000 cleared under K981371, K984056, K002881, K010608, K032226, K040540, and K051767); and · Versamed Medical Systems IVENT201 cleared under K981668, K01 1957, K021981, K042… | 2004 |
| * | K051767 | LTV 1000 VentilatorSummary page 1…HT50 Ventilator cleared under K992133; · Pulmonetic Systems LTV 1000 cleared under K981371, K984056, K002881, K010608, K032226, K040540, and K051767); and · Versamed Medical Systems IVENT201 cleared under K981668, K01 1957, K021981, K042468, K052554,… | 2005 |
| * | K981668 | Smartvent 201 Portable VentilatorSummary page 1…1000 cleared under K981371, K984056, K002881, K010608, K032226, K040540, and K051767); and · Versamed Medical Systems IVENT201 cleared under K981668, K01 1957, K021981, K042468, K052554, K053270, K061627. IV. Device Description The modified NEWPORT HT50 Vent… | 1999 |
| * | K011957 | Ivent 201 Portable VentilatorSummary page 1…ared under K981371, K984056, K002881, K010608, K032226, K040540, and K051767); and · Versamed Medical Systems IVENT201 cleared under K981668, K01 1957, K021981, K042468, K052554, K053270, K061627. IV. Device Description The modified NEWPORT HT50 Ventilator is… | 2001 |
| * | K021981 | Ivent 201 Portable VentilatorSummary page 1…6, K002881, K010608, K032226, K040540, and K051767); and · Versamed Medical Systems IVENT201 cleared under K981668, K01 1957, K021981, K042468, K052554, K053270, K061627. IV. Device Description The modified NEWPORT HT50 Ventilator is an electrically powered,… | 2003 |
| * | K042468 | Ivent 201 Portable VentilatorSummary page 1…1, K010608, K032226, K040540, and K051767); and · Versamed Medical Systems IVENT201 cleared under K981668, K01 1957, K021981, K042468, K052554, K053270, K061627. IV. Device Description The modified NEWPORT HT50 Ventilator is an electrically powered, microproc… | 2004 |
| * | K052554 | Modification to: Ivent 201 Portable VentilatorSummary page 1…K010608, K032226, K040540, and K051767); and · Versamed Medical Systems IVENT201 cleared under K981668, K01 1957, K021981, K042468, K052554, K053270, K061627. IV. Device Description The modified NEWPORT HT50 Ventilator is an electrically powered, microprocessor… | 2005 |
| * | K053270 | IVENT 201Summary page 1…K010608, K032226, K040540, and K051767); and · Versamed Medical Systems IVENT201 cleared under K981668, K01 1957, K021981, K042468, K052554, K053270, K061627. IV. Device Description The modified NEWPORT HT50 Ventilator is an electrically powered, microprocessor controll… | 2006 |
| * | K061627 | Modification to I Vent 201Summary page 1…K032226, K040540, and K051767); and · Versamed Medical Systems IVENT201 cleared under K981668, K01 1957, K021981, K042468, K052554, K053270, K061627. IV. Device Description The modified NEWPORT HT50 Ventilator is an electrically powered, microprocessor controlled, varia… | 2006 |
What descends from it? (9)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (6 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Aug 10, 2011 | Not classified | Z-1041-2012 | Device Design | The recall was initiated because Flight Medical Innovations Ltd. has identified a problem may occur when contact between an exposed unused wire and the grounding wire occurs. If this contact occurs the ventilator may reset and switch off. |
| Jul 22, 2009 | Not classified | Z-2384-2011 | Other | The recall was initiated because Newport Medical has confirmed that the HT50 Dual Pac Ventilator is not compatiable with the external battery pack (p/n BAT3300A) supplied with the previous single battery ventilator. The Dual Pac system… |
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.
- K023366Datex-Ohmeda 7900 Ventilator EnhancementsDatex-Ohmeda, Inc. · 2003 · 3 generations back · ◆ in the 2003 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
- K981072Esprit VentilatorRespironics, Inc. · 1998 · 3 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
- K090888Newport HT70 Family of VentilatorsNewport Medical Instruments, Inc. · 2009 · Cites it directly · ◆ in the 2009 descendants bar of FIG. 13 Class I recalls
- K111146Newport HT70 VentilatorNewport Medical Instruments, Inc. · 2011 · 2 generations on · ◆ in the 2011 descendants bar of FIG. 14 Class I recalls
Nearest 5 of 6; all are on the web page.
What does this lineage say?
- The line of descent spans 17 years and passes through 6 companies; a new generation was cleared every 1.8 years on median.
- 19 of the 61 ancestors have a recall of any class; 4 have a Class I recall.
- Of its descendants, K100753 (Flight Medical, Ltd., 2010) has gone furthest, with 5 descendants of its own.
- 3 other devices also cite its predicate K992133.
How does its category compare?
All CBK devicesCBK Ventilator, Continuous, Facility Use: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, 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 device is intended to provide continuous or intermittent mechanical ventilator support for the care of individuals who require mechanical ventilation. Specifically, the NEWPORT HT50 is applicable for adult and pediatric (i.e. infant, child and adolescent) patients, greater than or equal to 10 kg (22 lbs), who require the following general types of ventilatory support: positive pressure ventilation with Assist/Control, SIMV and SPONT/CPAP modes of…
Read the full statement (110 words)
The device is intended to provide continuous or intermittent mechanical ventilator support for the care of individuals who require mechanical ventilation. Specifically, the NEWPORT HT50 is applicable for adult and pediatric (i.e. infant, child and adolescent) patients, greater than or equal to 10 kg (22 lbs), who require the following general types of ventilatory support: positive pressure ventilation with Assist/Control, SIMV and SPONT/CPAP modes of ventilation.
The NEWPORT HT50 is a restricted medical device intended for use by qualified, trained personnel under the direction of a physician; it 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/K082724 · printed Nov 6, 2026
Cite this page
510(k) Report. “K082724: Newport HTS50 Ventilator with Dual Pac Battery System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K082724
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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