510(k) · Cleared
Recalled · 2009Tidal Wave Carbon Dioxide Monitor, Model 610
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Novametrix Medical Systems, Inc. · CCK Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase
Cleared on Nov 20, 1996 after an 89-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 4 of the 76 devices in its family, counting itself, have a Class I recall. 75 later devices descend from it. It has been recalled 4 times.
- Decided
- Nov 20, 1996
- Review
- 89 days
- Class
- Class II
- Product code
- CCK
- Recalls
- 4
- Predicates
- 0
75 later devices descend from it, 4 citing it directly. 4 of the 76 devices in this family, counting this one, have a Class I recall.
- This deviceK963327 Tidal Wave Carbon Dioxide Monitor, Model 610Novametrix Medical Systems, Inc. · 1996
- Descendant · cites it directly · 57 of its ownK032971 Tidal Wave SP Model 710/715 and 715Respironics Novametrix, Inc. · 2004 · Recalled
- Descendant · 2 generations on · 39 of its ownK083821 Vital Signs MonitorEdan Instruments, Inc. · 2009
- Descendant · 3 generations on · 16 of its ownK093016 Vital Signs MonitorShenzhen Creative Industry Co., Ltd. · 2010
- Descendant · cites it directly · 16 of its ownK051857 Veo Multigas Monitor for Pocket PC, Model 400221Weissburg Associates · 2005
- Descendant · 3 generations on · 15 of its ownK113623 Patient MonitorEdan Instruments, Inc. · 2012 · Recalled
Showing 5 of 75 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 75 · See all- K032971Tidal Wave SP Model 710/715 and 715Respironics Novametrix, Inc. · 2004 · cites it directly57descendants
- K083821Vital Signs MonitorEdan Instruments, Inc. · 2009 · 2 generations on39descendants
- K093016Vital Signs MonitorShenzhen Creative Industry Co., Ltd. · 2010 · 3 generations on16descendants
- K051857Veo Multigas Monitor for Pocket PC, Model 400221Weissburg Associates · 2005 · cites it directly16descendants
- K113623Patient MonitorEdan Instruments, Inc. · 2012 · 3 generations on15descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K963327 | Tidal Wave Carbon Dioxide Monitor, Model 610 | Novametrix Medical Systems, Inc. | 1996 | — |
| +1 | K032971 | Tidal Wave SP Model 710/715 and 715 | Respironics Novametrix, Inc. | 2004 | 7 |
| +2 | K083821 | Vital Signs Monitor | Edan Instruments, Inc. | 2009 | — |
| +3 | K093016 | Vital Signs Monitor | Shenzhen Creative Industry Co., Ltd. | 2010 | — |
| +1 | K051857 | Veo Multigas Monitor for Pocket PC, Model 400221 | Weissburg Associates | 2005 | — |
| +3 | K113623 | Patient Monitor | Edan Instruments, Inc. | 2012 | 2 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 2 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 2 | 0 |
| 2008 | 3 | 0 |
| 2009 | 1 | 0 |
| 2010 | 4 | 0 |
| 2011 | 2 | 0 |
| 2012 | 5 | 0 |
| 2013 | 4 | 0 |
| 2014 | 2 | 0 |
| 2015 | 2 | 0 |
| 2016 | 5 | 0 |
| 2017 | 2 | 0 |
| 2018 | 5 | 0 |
| 2019 | 3 | 2 |
| 2020 | 4 | 1 |
| 2021 | 6 | 1 |
| 2022 | 5 | 0 |
| 2023 | 3 | 0 |
| 2024 | 6 | 0 |
| 2025 | 5 | 0 |
| 2026 | 2 | 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.
4 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? (75)
See all 754 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (4 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Nov 19, 2009 | Not classified | Z-1289-2010 | Nonconforming Material/Component | Power cords' prongs may crack or fail -- Philips was notified that FDA is investigating whether certain types of Electri-Cord Manufacturing Company power cords used with medical devices may be defective in that the power cord's prongs may… |
| Nov 19, 2009 | Not classified | Z-1294-2010 | Nonconforming Material/Component | Power cords' prongs may crack or fail -- Philips was notified that FDA is investigating whether certain types of Electri-Cord Manufacturing Company power cords used with medical devices may be defective in that the power cord's prongs may… |
| Nov 19, 2009 | Not classified | Z-1283-2010 | Nonconforming Material/Component | Power cords' prongs may crack or fail -- Philips was notified that FDA is investigating whether certain types of Electri-Cord Manufacturing Company power cords used with medical devices may be defective in that the power cord's prongs may… |
| Nov 19, 2009 | Not classified | Z-1273-2010 | Nonconforming Material/Component | Power cords' prongs may crack or fail -- Philips was notified that FDA is investigating whether certain types of Electri-Cord Manufacturing Company power cords used with medical devices may be defective in that the power cord's prongs may… |
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.
- K193058SonarMed AirWave Airway Monitoring SystemSonarmed, Inc. · 2020 · 4 generations on · ◆ in the 2020 descendants bar of FIG. 14 Class I recalls
- K181170Trilogy Evo UniversalRespironics, Inc. · 2019 · 5 generations on · ◆ in the 2019 descendants bar of FIG. 112 Class I recalls
- K193586Vivo 45 LSBreas Medical AB · 2021 · 5 generations on · ◆ in the 2021 descendants bar of FIG. 11 Class I recall
- K181166Trilogy EvoRespironics, Inc. · 2019 · 5 generations on · ◆ in the 2019 descendants bar of FIG. 131 Class I recalls
What does this lineage say?
- Of its descendants, K032971 (Respironics Novametrix, Inc., 2004) has gone furthest, with 57 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/K963327 · printed Nov 4, 2026
Cite this page
510(k) Report. “K963327: Tidal Wave Carbon Dioxide Monitor, Model 610.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K963327
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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