510(k) · Cleared
ClearedCombitrans Monitoring Sets and Accessories
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
B.Braun Melsungen AG · DRS Transducer, Blood-Pressure, Extravascular
Cleared on Apr 7, 2011 as substantially equivalent to K070710 (Biosensors International-USA, 2007) after a 262-day review. Its family tree reaches back 2 generations to 1985.
- Decided
- Apr 7, 2011
- Review
- 262 days
- Class
- Class II
- Product code
- DRS
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K841788 (1985). 3 ancestors in all. No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K841788 | Utah Disposable Pressure Transducer | Utah Medical Products, Inc. | 1985 | — |
| −1 | K070710 | Accutrans Disposable Pressure Monitoring System | Biosensors International-USA | 2007 | — |
| 0 (this device) | K102033 | Combitrans Monitoring Sets and Accessories | B.Braun Melsungen AG | 2011 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 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 DRS? 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 DRS device
- #1 K242909 FloTrac sensors; FloTrac Jr sensors; Acumen IQ…score 17.4 · 29 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin 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 |
|---|---|---|---|
| * | K070710 | Accutrans Disposable Pressure Monitoring SystemSummary page 1…1 CER 870.2850 PREDICATE DEVICES: Accutrans® Disposable Pressure Monitoring System, Biosensors International, K070710, Class 11, DRS, 870,2850 DESCRIPTION: The Combitrans Monitoring… | 2007 |
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 26 years and passes through 3 companies; a new generation was cleared every 22.1 years on median.
- None of the 3 ancestors has a recall.
- 1 other device also cites its predicate K070710.
How does its category compare?
All DRS devicesDRS Transducer, Blood-Pressure, Extravascular: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.
FDA decisions per year · DRS
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DRS
186in 2016
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DRS
15in 2023
Class I (2 since 2007) Class II/III not classified
Adverse event reports per year · DRS
187in 2025
MAUDE reports naming product code DRS, 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 | 1 | — | 0 | 397 |
| 2008 | 0 | — | 0 | 531 |
| 2009 | 2 | — | 0 | 344 |
| 2010 | 2 | — | 0 | 115 |
| 2011 | 3 | 135 | 0 | 63 |
| 2012 | 1 | — | 0 | 43 |
| 2013 | 1 | — | 0 | 39 |
| 2014 | 1 | — | 0 | 23 |
| 2015 | 1 | — | 0 | 60 |
| 2016 | 3 | 186 | 162 | 89 |
| 2017 | 2 | — | 0 | 92 |
| 2018 | 0 | — | 11 | 82 |
| 2019 | 0 | — | 0 | 84 |
| 2020 | 0 | — | 0 | 41 |
| 2021 | 0 | — | 0 | 93 |
| 2022 | 0 | — | 0 | 95 |
| 2023 | 1 | — | 15 | 147 |
| 2024 | 0 | — | 0 | 205 |
| 2025 | 1 | — | 0 | 187 |
| 2026 | 1 | — | 2 (2) | — |
What is it indicated for?
The B. Braun Combitrans Monitoring Set is. intended for the extravascular measurement of venous, arterial, or pulmonary arterial blood pressure by converting hemodynamic waveforms into electrical signals.
The Combitrans flush device provides a continuous flush rate from approximately 3 mllhr and allows a switch to approximately 300 mI/hr. When using the Combitrans device in neonates, infants or small children a syringe pump should be used to control the flow rate, as the flow rate should not exceed 3 nmI/h.-
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K102033 · printed Nov 4, 2026
Cite this page
510(k) Report. “K102033: Combitrans Monitoring Sets and Accessories.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K102033
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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