510(k) · Cleared
Recalled · 2011Newport HT50 Ventilator with Humidifier HT50-H, Newport HT50 Ventilator Without Humidifier, HT50-H1, Newport HT50 Ventil
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 Aug 4, 2000 after a 408-day review. The FDA summary names its predicate without a number. 13 of the 34 devices in its family, counting itself, have a Class I recall. 33 later devices descend from it. It has been recalled 5 times.
- Decided
- Aug 4, 2000
- Review
- 408 days
- Class
- Class II
- Product code
- CBK
- Recalls
- 5
- Predicates
- 0
33 later devices descend from it, 4 citing it directly. 13 of the 34 devices in this family, counting this one, have a Class I recall.
- This deviceK992133 Newport HT50 Ventilator with Humidifier HT50-H, Newport HT50…Newport Medical Instruments, Inc. · 2000
- Descendant · cites it directly · 26 of its ownK083526 Trilogy 100 VentilatorRespironics Inc., Sleep & Home Respiratory Group · 2009 · Recalled (Class I)
- Descendant · 2 generations on · 19 of its ownK093416 Trilogy 200 VentilatorRespironics, Inc. · 2010 · Recalled (Class I)
- Descendant · 2 generations on · 11 of its ownK111610 Trilogy Series Ventilator with OximetryRespironics, Inc. · 2011 · Recalled (Class I)
- Descendant · 3 generations on · 10 of its ownK133868 Astral VentilatorResmed, Ltd. · 2014 · Recalled
- Descendant · 2 generations on · 9 of its ownK112754 IVENT101Versamed Medical Systems, Ltd. · 2012
Showing 5 of 33 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 33 · See all- K083526Trilogy 100 VentilatorRespironics Inc., Sleep & Home Respiratory Group · 2009 · cites it directly26descendants
- K093416Trilogy 200 VentilatorRespironics, Inc. · 2010 · 2 generations on19descendants
- K111610Trilogy Series Ventilator with OximetryRespironics, Inc. · 2011 · 2 generations on11descendants
- K133868Astral VentilatorResmed, Ltd. · 2014 · 3 generations on10descendants
- K112754IVENT101Versamed Medical Systems, Ltd. · 2012 · 2 generations on9descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K992133 | Newport HT50 Ventilator with Humidifier HT50-H, Newport HT50 Ventilator… | Newport Medical Instruments, Inc. | 2000 | — |
| +1 | K083526 | Trilogy 100 Ventilator | Respironics Inc., Sleep & Home Respiratory Group | 2009 | Class I |
| +2 | K093416 | Trilogy 200 Ventilator | Respironics, Inc. | 2010 | Class I |
| +2 | K111610 | Trilogy Series Ventilator with Oximetry | Respironics, Inc. | 2011 | Class I |
| +3 | K133868 | Astral Ventilator | Resmed, Ltd. | 2014 | 2 |
| +2 | K112754 | IVENT101 | Versamed Medical Systems, Ltd. | 2012 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2009 | 2 | 2 |
| 2010 | 2 | 1 |
| 2011 | 3 | 2 |
| 2012 | 6 | 1 |
| 2013 | 2 | 1 |
| 2014 | 2 | 0 |
| 2016 | 4 | 1 |
| 2017 | 1 | 1 |
| 2018 | 1 | 1 |
| 2019 | 3 | 2 |
| 2021 | 1 | 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.
13 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? (2)
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 |
|---|---|---|---|
| * | — | TBird Legacy Ventilator Named without a submission number | |
| * | — | Pulmonetics LTV1000 ventilator Named without a submission number |
What descends from it? (33)
See all 334 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (13 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. |
| May 14, 2010 | Not classified | Z-2382-2011 | Other | The recall was initiated because Newport Medical has confirmed that the Newport HT50 hard shell Emergency Preparedness (EP) Storage Cases must be relabeled to caution users to follow current labeling guidelines for charging the battery… |
| Jan 13, 2009 | Not classified | Z-2295-2011 | Other | The recall was initiated because Newport Medical Instruments confirmed that the Newport HT50 ventilators that were shipped in December 2008 were without the label on the top of the ventilator that reminds users to keep HT50 ventilators… |
| Jul 31, 2007 | Not classified | Z-1192-2007 | Other | Battery Life: With use over time, the internal battery begins losing its ability to hold a charge resulting in shortened ventilator operation time. Specifically, Newport has received a number of reports concerning the internal battery not… |
| Oct 29, 2005 | Not classified | Z-1375-05 | Other | Lack of alarm prior to shutdown. |
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 · Cites it directly · ◆ in the 2009 descendants bar of FIG. 13 Class I recalls
- K083526Trilogy 100 VentilatorRespironics Inc., Sleep & Home Respiratory Group · 2009 · Cites it directly · ◆ in the 2009 descendants bar of FIG. 15 Class I recalls
- K093416Trilogy 200 VentilatorRespironics, Inc. · 2010 · 2 generations on · ◆ in the 2010 descendants bar of FIG. 14 Class I recalls
- K111610Trilogy Series Ventilator with OximetryRespironics, Inc. · 2011 · 2 generations on · ◆ in the 2011 descendants bar of FIG. 12 Class I recalls
- K111146Newport HT70 VentilatorNewport Medical Instruments, Inc. · 2011 · 2 generations on · ◆ in the 2011 descendants bar of FIG. 14 Class I recalls
- K121623Bipap a 40 Ventilatory Support SystemRespironics, Inc. · 2012 · 3 generations on · ◆ in the 2012 descendants bar of FIG. 13 Class I recalls
- K181170Trilogy Evo UniversalRespironics, Inc. · 2019 · 3 generations on · ◆ in the 2019 descendants bar of FIG. 112 Class I recalls
- K181166Trilogy EvoRespironics, Inc. · 2019 · 3 generations on · ◆ in the 2019 descendants bar of FIG. 131 Class I recalls
- K122715Stellar 150Resmed Germany, Inc. · 2013 · 3 generations on · ◆ in the 2013 descendants bar of FIG. 11 Class I recall
- K162877VOCSN Unified Respiratory SystemVentec Life Systems, Inc. · 2017 · 3 generations on · ◆ in the 2017 descendants bar of FIG. 114 Class I recalls
- K152068Astral 100/150Resmed, Ltd. · 2016 · 4 generations on · ◆ in the 2016 descendants bar of FIG. 11 Class I recall
- K193586Vivo 45 LSBreas Medical AB · 2021 · 4 generations on · ◆ in the 2021 descendants bar of FIG. 11 Class I recall
Nearest 12 of 13 shown.
Nearest 5 of 13; all are on the web page.
What does this lineage say?
- Of its descendants, K083526 (Respironics Inc., Sleep & Home Respiratory Group, 2009) has gone furthest, with 26 descendants of its own.
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 device is intended to provide continuous or intermittent mechanical ventilator 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, greater than 10 kg or 22 lbs., who require the following general types of ventilatory support…
Read the full statement (112 words)
The device is intended to provide continuous or intermittent mechanical ventilator 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, greater than 10 kg or 22 lbs., who require the following general types of ventilatory support, as prescribed by an attending physician: positive pressure ventilation and assist/control. SIMV, CPAP modes of ventilation. The ventilator is suitable for use in post-acute, emergency room, home care environments (P/N HT50-H) and for transport applications (P/N HT50-T). Transport application is only applicable to the HT50-T.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K992133 · printed Nov 6, 2026
Cite this page
510(k) Report. “K992133: Newport HT50 Ventilator with Humidifier HT50-H, Newport HT50 Ventilator Without Humidifier, HT50-H1, Newport HT50 Ventil.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K992133
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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