510(k) · Cleared
Recalled · Class II · 2016Astral Ventilator
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Resmed, Ltd. · CBK Ventilator, Continuous, Facility Use
Cleared on Jun 4, 2014 as substantially equivalent to K093416 (Respironics, Inc., 2010) and 1 other predicate after a 166-day review. Its family tree reaches back 7 generations to 1991. 11 of the 66 devices in its family, counting itself, have a Class I recall. 10 later devices descend from it. It has been recalled 2 times.
- Decided
- Jun 4, 2014
- Review
- 166 days
- Class
- Class II
- Product code
- CBK
- Recalls
- 2
- Predicates
- 2
Its longest line of descent runs back 7 generations to K902859 (1991). 55 ancestors in all, the oldest K841279 (1984). 10 later devices descend from it, 2 citing it directly. 11 of the 66 devices in this family, counting this one, have a Class I recall.
- Root · 7 generations backK902859 Servo Ventilator 300Siemens Life Support Systems · 1991 · Recalled
- 6 generations backK960010 Servo Ventilator 300 Computer InterfaceSiemens Elema AB · 1996
- 5 generations backK970839 Servo Ventilator 300ASiemens Elema AB · 1997 · Recalled
- 4 generations backK992788 Bear Cub 750 PSVBear Medical Systems, Inc. · 1999
- 3 generations backK013642 AVEABird Products Corp. · 2002 · Recalled (Class I)
- 2 generations backK022674 Bird Avea VentilatorBird Products Corp. · 2002 · Recalled
- 1 generation backK060647 LTV 1200 VentilatorPulmonetic Systems, Inc. · 2006
- This deviceK133868 Astral VentilatorResmed, Ltd. · 2014
- Descendant · cites it directly · 7 of its ownK160481 Vivo 60Breas Medical AB · 2016 · Recalled
- Descendant · 2 generations on · 5 of its ownK181166 Trilogy EvoRespironics, Inc. · 2019 · Recalled (Class I)
- Descendant · 2 generations on · 2 of its ownK193586 Vivo 45 LSBreas Medical AB · 2021 · Recalled (Class I)
- Descendant · cites it directly · 1 of its ownK152068 Astral 100/150Resmed, Ltd. · 2016 · Recalled (Class I)
- Descendant · 3 generations on · 0 of its ownK232365 Vivo 45 LSOconnell Regulatory Consultants, Inc. · 2025
Showing 5 of 10 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 10 · See all- K160481Vivo 60Breas Medical AB · 2016 · cites it directly7descendants
- K181166Trilogy EvoRespironics, Inc. · 2019 · 2 generations on5descendants
- K193586Vivo 45 LSBreas Medical AB · 2021 · 2 generations on2descendants
- K152068Astral 100/150Resmed, Ltd. · 2016 · cites it directly1descendant
- K232365Vivo 45 LSOconnell Regulatory Consultants, Inc. · 2025 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K902859 | Servo Ventilator 300 | Siemens Life Support Systems | 1991 | 3 |
| −6 | K960010 | Servo Ventilator 300 Computer Interface | Siemens Elema AB | 1996 | — |
| −5 | K970839 | Servo Ventilator 300A | Siemens Elema AB | 1997 | 4 |
| −4 | K992788 | Bear Cub 750 PSV | Bear Medical Systems, Inc. | 1999 | — |
| −3 | K013642 | AVEA | Bird Products Corp. | 2002 | Class I |
| −2 | K022674 | Bird Avea Ventilator | Bird Products Corp. | 2002 | 5 |
| −1 | K060647 | LTV 1200 Ventilator | Pulmonetic Systems, Inc. | 2006 | — |
| 0 (this device) | K133868 | Astral Ventilator | Resmed, Ltd. | 2014 | — |
| +1 | K160481 | Vivo 60 | Breas Medical AB | 2016 | 2 |
| +2 | K181166 | Trilogy Evo | Respironics, Inc. | 2019 | Class I |
| +2 | K193586 | Vivo 45 LS | Breas Medical AB | 2021 | Class I |
| +1 | K152068 | Astral 100/150 | Resmed, Ltd. | 2016 | Class I |
| +3 | K232365 | Vivo 45 LS | Oconnell Regulatory Consultants, Inc. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1984 | 2 | 0 |
| 1990 | 4 | 0 |
| 1991 | 1 | 0 |
| 1992 | 2 | 0 |
| 1994 | 3 | 0 |
| 1995 | 3 | 0 |
| 1996 | 3 | 0 |
| 1997 | 2 | 0 |
| 1998 | 7 | 2 |
| 1999 | 4 | 0 |
| 2000 | 4 | 0 |
| 2001 | 4 | 0 |
| 2002 | 1 | 0 |
| 2003 | 3 | 1 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2007 | 1 | 0 |
| 2009 | 1 | 1 |
| 2010 | 1 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 2 | 1 |
| 2018 | 1 | 1 |
| 2019 | 2 | 2 |
| 2021 | 1 | 1 |
| 2024 | 2 | 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.
11 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 |
|---|---|---|---|
| * | K093416 | Trilogy 200 VentilatorSummary page 1…de NOLJ Class It Ventilator, continuous, facility use Predicate Devices Respironics Trilogy 200 (K093416) Pulmonetic LTV 1200 (K060647) Reason for submission New device Intended Use… | 2010 |
| * | K060647 | LTV 1200 VentilatorSummary page 1…Ventilator, continuous, facility use Predicate Devices Respironics Trilogy 200 (K093416) Pulmonetic LTV 1200 (K060647) Reason for submission New device Intended Use The Astral 100/150 provides continuous or intermittent ven… | 2006 |
What descends from it? (10)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (11 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jan 13, 2016 | Class II | Z-0746-2016 | Software design | Resmed Corporation is recalling Astral 100, 150 External Battery because of a start-up issue. |
| May 5, 2015 | Class II | Z-1750-2015 | Use error | The Astral device allows clinicians to disable all alarms including those that detect circuit disconnection. Inappropriate disabling of alarms in ventilator dependent patients can lead to hazards of insufficient ventilation and… |
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.
- K093416Trilogy 200 VentilatorRespironics, Inc. · 2010 · Direct predicate · ◆ in the 2010 ancestors bar of FIG. 14 Class I recalls
- K083526Trilogy 100 VentilatorRespironics Inc., Sleep & Home Respiratory Group · 2009 · 2 generations back · ◆ in the 2009 ancestors bar of FIG. 15 Class I recalls
- 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
- K152068Astral 100/150Resmed, Ltd. · 2016 · Cites it directly · ◆ in the 2016 descendants bar of FIG. 11 Class I recall
- K172875Astral 100/150Resmed, Ltd. · 2018 · 2 generations on · ◆ in the 2018 descendants bar of FIG. 12 Class I recalls
- K181170Trilogy Evo UniversalRespironics, Inc. · 2019 · 2 generations on · ◆ in the 2019 descendants bar of FIG. 112 Class I recalls
- K193586Vivo 45 LSBreas Medical AB · 2021 · 2 generations on · ◆ in the 2021 descendants bar of FIG. 11 Class I recall
- K181166Trilogy EvoRespironics, Inc. · 2019 · 2 generations on · ◆ in the 2019 descendants bar of FIG. 131 Class I recalls
Nearest 5 of 11; all are on the web page.
What does this lineage say?
- The line of descent spans 23 years and passes through 6 companies; a new generation was cleared every 2.7 years on median.
- 23 of the 55 ancestors have a recall of any class; 6 have a Class I recall.
- Of its descendants, K160481 (Breas Medical AB, 2016) has gone furthest, with 7 descendants of its own.
- 5 other devices also cite its predicate K093416.
How does its category compare?
All CBK devicesCBK Ventilator, Continuous, Facility Use: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, 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 Astral 1001150 provides continuous or intermittent ventilatory support for patients
weighing more than 5kg (11 Ib)who require mechanical ventilation. The Astral device is
Intended to be used in home, institution/hospltal and portable applications for both invasive
and non-invasive ventilation.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K133868 · printed Nov 6, 2026
Cite this page
510(k) Report. “K133868: Astral Ventilator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K133868
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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