510(k) · Cleared
ClearedBiotrend Oxygen Saturation and Hematocrit System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medtronic, Inc. · DTY Sensor, Blood-Gas, In-Line, Cardiopulmonary Bypass
Cleared on Feb 17, 2010 as substantially equivalent to K954501 (Medtronic Bio-Medicus, Inc., 1996) after an 84-day review. Its family tree reaches back 1 generation to 1996. 1 later device descends from it.
- Decided
- Feb 17, 2010
- Review
- 84 days
- Class
- Class II
- Product code
- DTY
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K954501 (1996). 1 later device descends from it, 1 citing it directly.
- Root · 1 generation backK954501 Biotrend Oxygen Saturation & Hematocrit SystemMedtronic Bio-Medicus, Inc. · 1996
- This deviceK093650 Biotrend Oxygen Saturation and Hematocrit SystemMedtronic, Inc. · 2010
- Descendant · cites it directly · 0 of its ownK133157 Tri-Optic Measurement Cell; with Balance Biosurface, with Carmeda…Medtronic, Inc. · 2014
Most influential descendants
Showing 1 of 1 · See all- K133157Tri-Optic Measurement Cell; with Balance Biosurface, with Carmeda Bioactive Surface…Medtronic, Inc. · 2014 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K954501 | Biotrend Oxygen Saturation & Hematocrit System | Medtronic Bio-Medicus, Inc. | 1996 | — |
| 0 (this device) | K093650 | Biotrend Oxygen Saturation and Hematocrit System | Medtronic, Inc. | 2010 | — |
| +1 | K133157 | Tri-Optic Measurement Cell; with Balance Biosurface, with Carmeda Bioactive… | Medtronic, Inc. | 2014 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 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 |
|---|---|---|---|
| * | K954501 | Biotrend Oxygen Saturation & Hematocrit SystemSummary page 1…DTY Classification: Class 11 Predicate Device BioTrend®Oxygen Saturation and Hemnatocrit System (K954501) Device Description The modified RioTrend Oxygen Saturation and Hemnatocrit System is an on-line monitoring… | 1996 |
| † | K910421 | Saturation/Hematocrit Monitor System | 1991 |
| † | K012743 | Trillium Tri-Optic Measurement Cell, Model TMC 25T, TMC38 T, TMC 50T | 2001 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K133157 | Tri-Optic Measurement Cell; with Balance Biosurface, with Carmeda Bioactive Surface… | 2014 | 0 |
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?
- Its one ancestor has no recall.
- Of its descendants, K133157 (Medtronic, Inc., 2014) has gone furthest, with 0 descendants 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. 2010, this device’s year, is highlighted.
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 BioTrend Oxygen Saturation and Hemnatocrit Systemn measures percent oxygen saturation and hemnatocrit of the blood in the extracorporeal circuit. The extracorporeal circuit is used for, but is not limited to, cardiopulmonary bypass, closed-chiest support, and limnb perfusion.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K093650 · printed Nov 4, 2026
Cite this page
510(k) Report. “K093650: Biotrend Oxygen Saturation and Hematocrit System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K093650
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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