510(k) · Cleared
ClearedCM02 Cuvette, 1/2, CM02 Cuvette, 3/8 and CM02 Cuvette, 1/4
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
International Biophysics Corp. · DTY Sensor, Blood-Gas, In-Line, Cardiopulmonary Bypass
Cleared on Mar 20, 1997 after a 185-day review. The FDA summary names its predicate without a number. 2 later devices descend from it.
- Decided
- Mar 20, 1997
- Review
- 185 days
- Class
- Class II
- Product code
- DTY
- Recalls
- None
- Predicates
- 0
2 later devices descend from it, 2 citing it directly.
- This deviceK963698 CM02 Cuvette, 1/2, CM02 Cuvette, 3/8 and CM02 Cuvette, 1/4International Biophysics Corp. · 1997
- Descendant · cites it directly · 1 of its ownK972574 Stela Model UJ45 Pacing LeadsEla Medical, Inc. · 1998
- Descendant · cites it directly · 0 of its ownK993448 Stela UT46 and BT45/46 Straight Tined Pacing Leads, Stela UJ45 and…Ela Medical, Inc. · 2000
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K963698 | CM02 Cuvette, 1/2, CM02 Cuvette, 3/8 and CM02 Cuvette, 1/4 | International Biophysics Corp. | 1997 | — |
| +1 | K972574 | Stela Model UJ45 Pacing Leads | Ela Medical, Inc. | 1998 | — |
| +1 | K993448 | Stela UT46 and BT45/46 Straight Tined Pacing Leads, Stela UJ45 and BJ44/45… | Ela Medical, Inc. | 2000 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 2000 | 1 | 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.
Planning a device in DTY? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin 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 |
|---|---|---|---|
| * | — | Bentley OTC Flow Through Cuvette Named without a submission number |
What descends from it? (2)
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, K972574 (Ela Medical, Inc., 1998) has gone furthest, with 1 descendant of its own.
How does its category compare?
All DTY devicesDTY Sensor, Blood-Gas, In-Line, Cardiopulmonary Bypass: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · DTY
1in 2010
2026 to Oct 25, outlined.
Median 510(k) review, days · DTY
Too few DTY 510(k)s in any year since 2007 to give a median.
Recalls per year · DTY
2in 2010
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DTY
3in 2015
MAUDE reports naming product code DTY, 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 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 1 | — | 2 | 130 |
| 2011 | 0 | — | 0 | 158 |
| 2012 | 0 | — | 0 | 20 |
| 2013 | 0 | — | 0 | 18 |
| 2014 | 0 | — | 0 | 8 |
| 2015 | 0 | — | 0 | 3 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The IBC CMO2 Flow Through Cuvette is a single piece, single use, disposable component intended for use with the Bentley OxySat Monitor as a direct substitute for the Bentley OTC Flow Through Cuvette.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K963698 · printed Nov 4, 2026
Cite this page
510(k) Report. “K963698: CM02 Cuvette, 1/2, CM02 Cuvette, 3/8 and CM02 Cuvette, 1/4.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K963698
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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