510(k) · Cleared
ClearedTri-Optic Measurement Cell; with Balance Biosurface, with Carmeda Bioactive Surface, with Trillium Biosurface, with 6
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medtronic, Inc. · DRY Monitor, Blood-Gas, On-Line, Cardiopulmonary Bypass
Cleared on Oct 23, 2014 as substantially equivalent to K910421 (Medtronic Vascular, 1991) and 2 other predicates after a 371-day review. Its family tree reaches back 2 generations to 1991.
- Decided
- Oct 23, 2014
- Review
- 371 days
- Class
- Class II
- Product code
- DRY
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 2 generations to K910421 (1991). 5 ancestors in all. No later device cites it as a predicate yet.
- Root · 2 generations backK910421 Saturation/Hematocrit Monitor SystemMedtronic Vascular · 1991
- 1 generation backK012743 Trillium Tri-Optic Measurement Cell, Model TMC 25T, TMC38 T, TMC 50TMedtronic Perfusion Systems · 2001
- This deviceK133157 Tri-Optic Measurement Cell; with Balance Biosurface, with Carmeda…Medtronic, Inc. · 2014
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K910421 | Saturation/Hematocrit Monitor System | Medtronic Vascular | 1991 | — |
| −1 | K012743 | Trillium Tri-Optic Measurement Cell, Model TMC 25T, TMC38 T, TMC 50T | Medtronic Perfusion Systems | 2001 | — |
| 0 (this device) | K133157 | Tri-Optic Measurement Cell; with Balance Biosurface, with Carmeda Bioactive… | Medtronic, Inc. | 2014 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 1998 | 1 | 0 |
| 2010 | 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 DRY? 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 DRY device
- #1 K234065 CDI OneView Monitoring Systemscore 5.5 · 2 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (3)
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 |
|---|---|---|---|
| * | K910421 | Saturation/Hematocrit Monitor SystemSummary page 4…mber: 21 CFR 870.4330 Product Code: DRY Classification: Class II Predicate Devices Medtronic MX2 Oxygen Saturation and Hematocrit Monitoring System (K910421) Medtronic BioTrend Oxygen Saturation and Hematocrit System (K093650) Medtronic Tri-optic Measurement Cell with Trillium Biosurfa… | 1991 |
| * | K093650 | Biotrend Oxygen Saturation and Hematocrit SystemSummary page 4…Class II Predicate Devices Medtronic MX2 Oxygen Saturation and Hematocrit Monitoring System (K910421) Medtronic BioTrend Oxygen Saturation and Hematocrit System (K093650) Medtronic Tri-optic Measurement Cell with Trillium Biosurface (K012743) Device Description The Medtronic Tri-optic Measurement… | 2010 |
| * | K012743 | Trillium Tri-Optic Measurement Cell, Model TMC 25T, TMC38 T, TMC 50TSummary page 4…ematocrit Monitoring System (K910421) Medtronic BioTrend Oxygen Saturation and Hematocrit System (K093650) Medtronic Tri-optic Measurement Cell with Trillium Biosurface (K012743) Device Description The Medtronic Tri-optic Measurement Cell is a sterile, single-use cell used with the BioTrend Oxygen Saturat… | 2001 |
What descends from it?
No later submission names this one as a predicate yet.
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?
- The line of descent spans 23 years and passes through 3 companies; a new generation was cleared every 13.1 years on median.
- 1 of the 5 ancestors has a recall of any class.
- 2 other devices also cite its predicate K910421.
How does its category compare?
All DRY devicesDRY Monitor, Blood-Gas, On-Line, Cardiopulmonary Bypass: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, this device’s year, is highlighted.
FDA decisions per year · DRY
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · DRY
88in 2018
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DRY
1in 2020
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DRY
134in 2025
MAUDE reports naming product code DRY, 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 | 2 | — | 0 | 0 |
| 2008 | 0 | — | 1 | 1 |
| 2009 | 2 | — | 0 | 2 |
| 2010 | 0 | — | 6 | 1,070 |
| 2011 | 2 | — | 14 | 2,268 |
| 2012 | 1 | — | 5 | 167 |
| 2013 | 0 | — | 0 | 157 |
| 2014 | 2 | — | 0 | 156 |
| 2015 | 0 | — | 1 | 231 |
| 2016 | 0 | — | 0 | 240 |
| 2017 | 1 | — | 0 | 61 |
| 2018 | 3 | 88 | 0 | 165 |
| 2019 | 0 | — | 0 | 63 |
| 2020 | 1 | — | 1 | 35 |
| 2021 | 1 | — | 0 | 42 |
| 2022 | 0 | — | 0 | 37 |
| 2023 | 0 | — | 0 | 41 |
| 2024 | 1 | — | 0 | 72 |
| 2025 | 0 | — | 0 | 134 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The BioTrend oxygen saturation and hematocrit system measures percent oxygen saturation and hematocrit of the blood in the extracorporeal circuit. The extracorporeal circuit is used for, but is not limited to, cardiopulmonary bypass, closed-chest support, and limb perfusion.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K133157 · printed Nov 6, 2026
Cite this page
510(k) Report. “K133157: Tri-Optic Measurement Cell; with Balance Biosurface, with Carmeda Bioactive Surface, with Trillium Biosurface, with 6.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K133157
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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