510(k) · Cleared
ClearedTonocap, TC-200 and Accessory Catheters
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Instrumentarium Corp. · CCK Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase
Cleared on Apr 4, 1997 after a 273-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 4 later devices descend from it.
- Decided
- Apr 4, 1997
- Review
- 273 days
- Class
- Class II
- Product code
- CCK
- Recalls
- None
- Predicates
- 0
4 later devices descend from it, 2 citing it directly.
- This deviceK962638 Tonocap, TC-200 and Accessory CathetersInstrumentarium Corp. · 1997
- Descendant · cites it directly · 1 of its ownK984579 Capno Probe aOptical Sensors, Inc. · 2000
- Descendant · cites it directly · 1 of its ownK993656 Datex-Ohmeda Tonometry Module M-TonoDatex-Ohmeda, Inc. · 2000
- Descendant · 2 generations on · 0 of its ownK212425 MicroTrend SystemExostat Medical, Inc. · 2024
- Descendant · 2 generations on · 0 of its ownK052167 Datex-Ohmeda S/5 Tonometry Module, E Tono and AccessoriesGE Healthcare · 2005
Most influential descendants
Showing 4 of 4 · See all- K984579Capno Probe aOptical Sensors, Inc. · 2000 · cites it directly1descendant
- K993656Datex-Ohmeda Tonometry Module M-TonoDatex-Ohmeda, Inc. · 2000 · cites it directly1descendant
- K212425MicroTrend SystemExostat Medical, Inc. · 2024 · 2 generations on0descendants
- K052167Datex-Ohmeda S/5 Tonometry Module, E Tono and AccessoriesGE Healthcare · 2005 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K962638 | Tonocap, TC-200 and Accessory Catheters | Instrumentarium Corp. | 1997 | — |
| +1 | K984579 | Capno Probe a | Optical Sensors, Inc. | 2000 | — |
| +1 | K993656 | Datex-Ohmeda Tonometry Module M-Tono | Datex-Ohmeda, Inc. | 2000 | — |
| +2 | K212425 | MicroTrend System | Exostat Medical, Inc. | 2024 | — |
| +2 | K052167 | Datex-Ohmeda S/5 Tonometry Module, E Tono and Accessories | GE Healthcare | 2005 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 2 | 0 |
| 2005 | 1 | 0 |
| 2024 | 1 | 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.
Planning a device in CCK? 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? (4)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K984579 (Optical Sensors, Inc., 2000) has gone furthest, with 1 descendant 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/K962638 · printed Nov 6, 2026
Cite this page
510(k) Report. “K962638: Tonocap, TC-200 and Accessory Catheters.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K962638
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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