510(k) · Cleared
ClearedAS/3(TM) Anesthesia Monitor Syst Interface Board
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Datex Division Instrumentarium Corp. · CCK Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase
Cleared on Aug 1, 1994 after a 259-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 4 later devices descend from it.
- Decided
- Aug 1, 1994
- Review
- 259 days
- Class
- Class II
- Product code
- CCK
- Recalls
- None
- Predicates
- 0
4 later devices descend from it, 2 citing it directly.
- This deviceK935477 AS/3(TM) Anesthesia Monitor Syst Interface BoardDatex Division Instrumentarium Corp. · 1994
- Descendant · cites it directly · 2 of its ownK012531 Datex-Ohmeda S/5 Device Interfacing Solution, N-DisxxxxDatex-Ohmeda · 2001
- Descendant · 2 generations on · 1 of its ownK051634 Datex-Ohmeda S/5 Device Interfacing SolutionGE Healthcare · 2005
- Descendant · 3 generations on · 0 of its ownK070421 Datex-Ohmeda S/5 Device Interfacing Solution, N-Disxxxx..01 with…GE Healthcare · 2007 · Recalled
- Descendant · cites it directly · 0 of its ownK052880 Datex-Ohmeda S/5 Interface Module E-IntGE Healthcare · 2005
Most influential descendants
Showing 4 of 4 · See all- K012531Datex-Ohmeda S/5 Device Interfacing Solution, N-DisxxxxDatex-Ohmeda · 2001 · cites it directly2descendants
- K051634Datex-Ohmeda S/5 Device Interfacing SolutionGE Healthcare · 2005 · 2 generations on1descendant
- K070421Datex-Ohmeda S/5 Device Interfacing Solution, N-Disxxxx..01 with N-Disvent..02GE Healthcare · 2007 · 3 generations on0descendants
- K052880Datex-Ohmeda S/5 Interface Module E-IntGE Healthcare · 2005 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K935477 | AS/3(TM) Anesthesia Monitor Syst Interface Board | Datex Division Instrumentarium Corp. | 1994 | — |
| +1 | K012531 | Datex-Ohmeda S/5 Device Interfacing Solution, N-Disxxxx | Datex-Ohmeda | 2001 | — |
| +2 | K051634 | Datex-Ohmeda S/5 Device Interfacing Solution | GE Healthcare | 2005 | — |
| +3 | K070421 | Datex-Ohmeda S/5 Device Interfacing Solution, N-Disxxxx..01 with N-Disvent..02 | GE Healthcare | 2007 | 1 |
| +1 | K052880 | Datex-Ohmeda S/5 Interface Module E-Int | GE Healthcare | 2005 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
| 2005 | 2 | 0 |
| 2007 | 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 has not posted a summary or statement for it, 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, K012531 (Datex-Ohmeda, 2001) has gone furthest, with 2 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/K935477 · printed Nov 4, 2026
Cite this page
510(k) Report. “K935477: AS/3(TM) Anesthesia Monitor Syst Interface Board.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K935477
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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