510(k) · Cleared
ClearedCombination Oximeter/Carbon Dioxide Gas Analyzer
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 May 9, 1997 as substantially equivalent to K950387 (Spegas Industries, Ltd., 1995) after a 198-day review. Its family tree reaches back 1 generation to 1995. 2 of the 44 devices in its family, counting itself, have a Class I recall. 42 later devices descend from it.
- Decided
- May 9, 1997
- Review
- 198 days
- Class
- Class II
- Product code
- CCK
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K950387 (1995). 42 later devices descend from it, 7 citing it directly. 2 of the 44 devices in this family, counting this one, have a Class I recall.
- Root · 1 generation backK950387 GeminiSpegas Industries, Ltd. · 1995
- This deviceK964239 Combination Oximeter/Carbon Dioxide Gas AnalyzerSpegas Industries, Ltd. · 1997
- Descendant · cites it directly · 20 of its ownK024300 Microcap Plus/NPB-75Oridion Medical 1987, Ltd. · 2003
- Descendant · 2 generations on · 12 of its ownK063752 Lifesense, Model LS1-9RNonin Medical, Inc. · 2007
- Descendant · cites it directly · 11 of its ownK983635 Julian Anesthesia Workstation, Model # JulianDraeger Medical, Inc. · 1999
- Descendant · 2 generations on · 10 of its ownK042607 Primus USDraeger Medical, Inc. · 2004 · Recalled
- Descendant · 3 generations on · 7 of its ownK092101 Reusable Pulse Oximeter Sensor, Model 8000 SeriesNonin Medical, Inc. · 2009
Showing 5 of 42 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 42 · See all- K024300Microcap Plus/NPB-75Oridion Medical 1987, Ltd. · 2003 · cites it directly20descendants
- K063752Lifesense, Model LS1-9RNonin Medical, Inc. · 2007 · 2 generations on12descendants
- K983635Julian Anesthesia Workstation, Model # JulianDraeger Medical, Inc. · 1999 · cites it directly11descendants
- K042607Primus USDraeger Medical, Inc. · 2004 · 2 generations on10descendants
- K092101Reusable Pulse Oximeter Sensor, Model 8000 SeriesNonin Medical, Inc. · 2009 · 3 generations on7descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K950387 | Gemini | Spegas Industries, Ltd. | 1995 | — |
| 0 (this device) | K964239 | Combination Oximeter/Carbon Dioxide Gas Analyzer | Spegas Industries, Ltd. | 1997 | — |
| +1 | K024300 | Microcap Plus/NPB-75 | Oridion Medical 1987, Ltd. | 2003 | — |
| +2 | K063752 | Lifesense, Model LS1-9R | Nonin Medical, Inc. | 2007 | — |
| +1 | K983635 | Julian Anesthesia Workstation, Model # Julian | Draeger Medical, Inc. | 1999 | — |
| +2 | K042607 | Primus US | Draeger Medical, Inc. | 2004 | 2 |
| +3 | K092101 | Reusable Pulse Oximeter Sensor, Model 8000 Series | Nonin Medical, Inc. | 2009 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 3 | 0 |
| 1999 | 2 | 0 |
| 2001 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 3 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 3 | 0 |
| 2010 | 2 | 0 |
| 2011 | 2 | 0 |
| 2012 | 1 | 0 |
| 2014 | 3 | 1 |
| 2015 | 5 | 0 |
| 2016 | 1 | 0 |
| 2018 | 2 | 0 |
| 2019 | 3 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2023 | 1 | 1 |
| 2024 | 2 | 0 |
| 2025 | 1 | 0 |
| 2026 | 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.
2 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? (1)
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 |
|---|---|---|---|
| * | K950387 | GeminiSummary page 2…ISTING FDA FORM 2892: A 733250 DOC: 2.1 MICROCAP/NPB-75 Sectiion 2.1.1 DEVICE DESCRIPTION The Spegas MicroCap/NPB-75 and the comparison device Gemini+ (K950387) are integrated instruments that measure end tidal CO2 (EtCO») and saturated arterial oxygen (SpO2). As a derivative of the EtCO… | 1995 |
What descends from it? (42)
See all 427 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K024300 | Microcap Plus/NPB-75 | 2003 | 20 |
| K983635 | Julian Anesthesia Workstation, Model # Julian | 1999 | 11 |
| K980325 | Microstream Nasal Cannula Filterline | 1998 | 2 |
| K980327 | Microstream Filterline Icu | 1998 | 2 |
| K980324 | Microstream Fillerline or/Ems | 1998 | 1 |
| K031741 | Medley ETCO2 Module (Includes Accessories), Model 8300 | 2004 | 0 |
| K982969 | Nonin Pulse Oximeter and Carbon Dioxide Detector, Models 9843, 9845 and 9847 | 1999 | 0 |
Has anything in its family been recalled? (2 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.
What does this lineage say?
- Its one ancestor has no recall.
- Of its descendants, K024300 (Oridion Medical 1987, Ltd., 2003) has gone furthest, with 20 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/K964239 · printed Nov 6, 2026
Cite this page
510(k) Report. “K964239: Combination Oximeter/Carbon Dioxide Gas Analyzer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K964239
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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