510(k) · Cleared
ClearedCapnosat
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Spegas Industries, Ltd. · CCK Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase
Cleared on Feb 21, 1995 after a 250-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 57 of the 213 devices in its family, counting itself, have a Class I recall. 212 later devices descend from it.
- Decided
- Feb 21, 1995
- Review
- 250 days
- Class
- Class II
- Product code
- CCK
- Recalls
- None
- Predicates
- 0
212 later devices descend from it, 1 citing it directly. 57 of the 213 devices in this family, counting this one, have a Class I recall.
- This deviceK942849 CapnosatSpegas Industries, Ltd. · 1995
- Descendant · cites it directly · 211 of its ownK961687 EVITA 4Drager, Inc. · 1996
- Descendant · 2 generations on · 174 of its ownK970460 Nellcor Puritan Bennett, 840 Ventilator System (Model 840)Puritan Bennett Corp. · 1998 · Recalled (Class I)
- Descendant · 2 generations on · 140 of its ownK970165 Evita 2 DuraDrager, Inc. · 1997
- Descendant · 2 generations on · 133 of its ownK013642 AVEABird Products Corp. · 2002 · Recalled (Class I)
- Descendant · 3 generations on · 114 of its ownK032451 Bird Tbird Vela VentilatorBird Products Corp. · 2004 · Recalled
Showing 5 of 212 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 212 · See all- K961687EVITA 4Drager, Inc. · 1996 · cites it directly211descendants
- K970460Nellcor Puritan Bennett, 840 Ventilator System (Model 840)Puritan Bennett Corp. · 1998 · 2 generations on174descendants
- K970165Evita 2 DuraDrager, Inc. · 1997 · 2 generations on140descendants
- K013642AVEABird Products Corp. · 2002 · 2 generations on133descendants
- K032451Bird Tbird Vela VentilatorBird Products Corp. · 2004 · 3 generations on114descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K942849 | Capnosat | Spegas Industries, Ltd. | 1995 | — |
| +1 | K961687 | EVITA 4 | Drager, Inc. | 1996 | — |
| +2 | K970460 | Nellcor Puritan Bennett, 840 Ventilator System (Model 840) | Puritan Bennett Corp. | 1998 | Class I |
| +2 | K970165 | Evita 2 Dura | Drager, Inc. | 1997 | — |
| +2 | K013642 | AVEA | Bird Products Corp. | 2002 | Class I |
| +3 | K032451 | Bird Tbird Vela Ventilator | Bird Products Corp. | 2004 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 1998 | 3 | 2 |
| 1999 | 2 | 1 |
| 2002 | 5 | 2 |
| 2003 | 1 | 0 |
| 2004 | 12 | 2 |
| 2005 | 8 | 0 |
| 2006 | 11 | 1 |
| 2007 | 7 | 2 |
| 2008 | 14 | 3 |
| 2009 | 8 | 2 |
| 2010 | 11 | 3 |
| 2011 | 15 | 7 |
| 2012 | 18 | 5 |
| 2013 | 10 | 4 |
| 2014 | 8 | 2 |
| 2015 | 8 | 1 |
| 2016 | 10 | 3 |
| 2017 | 11 | 5 |
| 2018 | 3 | 1 |
| 2019 | 9 | 3 |
| 2020 | 4 | 3 |
| 2021 | 7 | 3 |
| 2022 | 1 | 0 |
| 2023 | 6 | 2 |
| 2024 | 5 | 0 |
| 2025 | 6 | 0 |
| 2026 | 7 | 0 |
Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
57 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 CCK device
- #1 K253030 Capnostream™35 Portable Respiratory Monitor…score 15.8 · 16 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against?
FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
What descends from it? (212)
See all 2121 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K961687 | EVITA 4 | 1996 | 211 |
Has anything in its family been recalled? (57 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.
- K013642AVEABird Products Corp. · 2002 · 2 generations on · ◆ in the 2002 descendants bar of FIG. 113 Class I recalls
- K984535Puritan-Bennett 840 Ventilatory System with Bilevel OptionPuritan Bennett Corp. · 1998 · 2 generations on · ◆ in the 1998 descendants bar of FIG. 11 Class I recall
- K023350Esprit Ventilator with Respiratory MechanicsRespironics California, Inc. · 2002 · 2 generations on · ◆ in the 2002 descendants bar of FIG. 11 Class I recall
- K093632Infinity Acute Care System Workstation Neonatal CareDrager Medical AG & Co. Kgaa · 2010 · 2 generations on · ◆ in the 2010 descendants bar of FIG. 14 Class I recalls
- K042419Fabius GS/Fabius Tiro Anesthesia SystemDraeger Medical, Inc. · 2004 · 2 generations on · ◆ in the 2004 descendants bar of FIG. 14 Class I recalls
- K993071Puritan-Bennett Ventilator System with ET/Tracheostomy Tube Compensation, TC, Option, Model 840Puritan Bennett Corp. · 1999 · 2 generations on · ◆ in the 1999 descendants bar of FIG. 11 Class I recall
- K970460Nellcor Puritan Bennett, 840 Ventilator System (Model 840)Puritan Bennett Corp. · 1998 · 2 generations on · ◆ in the 1998 descendants bar of FIG. 11 Class I recall
- K053388Model 840 Ventilator with Proportional Assist Ventilation Plus Software OptionPuritan Bennett Corp. · 2006 · 3 generations on · ◆ in the 2006 descendants bar of FIG. 11 Class I recall
- K034040Esprit Ventilator, Model V1000Respironics, Inc. · 2004 · 3 generations on · ◆ in the 2004 descendants bar of FIG. 11 Class I recall
- K072884Fabius MriDraeger Medical AG & Co. KG · 2008 · 3 generations on · ◆ in the 2008 descendants bar of FIG. 11 Class I recall
- K121225Hamilton-C2Hamilton Medical AG · 2012 · 3 generations on · ◆ in the 2012 descendants bar of FIG. 11 Class I recall
- K070594Palmtop Ventilator, Models PTV-8, PTV-10Pulmonetic Systems, Inc. · 2007 · 4 generations on · ◆ in the 2007 descendants bar of FIG. 12 Class I recalls
Nearest 12 of 57 shown.
Nearest 5 of 57; all are on the web page.
What does this lineage say?
- Of its descendants, K961687 (Drager, Inc., 1996) has gone furthest, with 211 descendants of its own.
How does its category compare?
All CCK devicesCCK Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · CCK
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · CCK
169in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · CCK
1in 2022
Class I (8 since 2007) Class II/III not classified
Adverse event reports per year · CCK
1,259in 2025
MAUDE reports naming product code CCK, 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 | 5 | 56 | 0 | 7 |
| 2008 | 3 | 248 | 1 | 20 |
| 2009 | 3 | 101 | 19 | 21 |
| 2010 | 3 | 125 | 4 | 12 |
| 2011 | 2 | — | 14 | 18 |
| 2012 | 7 | 150 | 3 | 13 |
| 2013 | 4 | 132 | 2 (1) | 28 |
| 2014 | 9 | 166 | 0 | 51 |
| 2015 | 5 | 105 | 1 | 114 |
| 2016 | 2 | — | 0 | 88 |
| 2017 | 5 | 134 | 0 | 58 |
| 2018 | 6 | 296 | 5 | 63 |
| 2019 | 7 | 261 | 7 (7) | 141 |
| 2020 | 4 | 188 | 1 | 2,302 |
| 2021 | 4 | 227 | 0 | 2,272 |
| 2022 | 3 | 226 | 1 | 2,475 |
| 2023 | 4 | 555 | 0 | 1,637 |
| 2024 | 3 | 592 | 0 | 1,216 |
| 2025 | 3 | 169 | 0 | 1,259 |
| 2026 | 3 | 224 | 0 | — |
https://510kreport.com/device/K942849 · printed Nov 6, 2026
Cite this page
510(k) Report. “K942849: Capnosat.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K942849
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026