510(k) · Cleared
ClearedThermodilution Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biosensors Intl. Pte., Ltd. · DQO Catheter, Intravascular, Diagnostic
Cleared on Jan 5, 2010 as substantially equivalent to K911710 (Sunscope Intl., Inc., 1991) after a 414-day review. Its family tree reaches back 1 generation to 1991. 2 later devices descend from it.
- Decided
- Jan 5, 2010
- Review
- 414 days
- Class
- Class II
- Product code
- DQO
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K911710 (1991). 2 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK911710 Heparin Coated Thermodilution Cath & AccessoriesSunscope Intl., Inc. · 1991
- This deviceK083384 Thermodilution CatheterBiosensors Intl. Pte., Ltd. · 2010
- Descendant · cites it directly · 0 of its ownK094048 Percupro Messenger Balloon CatheterCardiosolutions, Inc. · 2011
- Descendant · cites it directly · 0 of its ownK101669 Thermodilution CatheterBiosensors Intl. Pte., Ltd. · 2010
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 |
|---|---|---|---|---|---|
| −1 | K911710 | Heparin Coated Thermodilution Cath & Accessories | Sunscope Intl., Inc. | 1991 | — |
| 0 (this device) | K083384 | Thermodilution Catheter | Biosensors Intl. Pte., Ltd. | 2010 | — |
| +1 | K094048 | Percupro Messenger Balloon Catheter | Cardiosolutions, Inc. | 2011 | — |
| +1 | K101669 | Thermodilution Catheter | Biosensors Intl. Pte., Ltd. | 2010 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2011 | 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 DQO? 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 DQO device
- #1 K254278 Arterial Pressure Monitoring Set/Trayscore 14.4 · 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? (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 |
|---|---|---|---|
| * | K911710 | Heparin Coated Thermodilution Cath & AccessoriesSummary page 1…Identification Trade Name: Themmedilution Catheter and Accessories Classification Name: Diagnostic Intravascular Catheter Predicate Davices Thermodilution Catheter (K911710) Device Description Biosensors flow-directed Thermodilution catheter is fabricated from extruded tubing, connected to a hub car… | 1991 |
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?
- Its one ancestor has no recall.
- Of its descendants, K094048 (Cardiosolutions, Inc., 2011) has gone furthest, with 0 descendants of its own.
How does its category compare?
All DQO devicesDQO Catheter, Intravascular, Diagnostic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, this device’s year, is highlighted.
FDA decisions per year · DQO
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DQO
148in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DQO
1in 2023
Class I (11 since 2007) Class II/III not classified
Adverse event reports per year · DQO
656in 2025
MAUDE reports naming product code DQO, 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 | 8 | 106 | 14 | 564 |
| 2008 | 3 | 80 | 4 | 726 |
| 2009 | 8 | 58 | 7 | 933 |
| 2010 | 7 | 137 | 11 | 556 |
| 2011 | 6 | 74 | 7 | 625 |
| 2012 | 15 | 94 | 2 | 532 |
| 2013 | 2 | — | 1 | 753 |
| 2014 | 3 | 109 | 0 | 601 |
| 2015 | 10 | 209 | 1 (1) | 628 |
| 2016 | 4 | 89 | 2 (1) | 614 |
| 2017 | 10 | 176 | 1 | 873 |
| 2018 | 10 | 234 | 2 | 777 |
| 2019 | 6 | 113 | 71 | 386 |
| 2020 | 3 | 30 | 4 (4) | 312 |
| 2021 | 1 | — | 0 | 338 |
| 2022 | 4 | 181 | 1 | 379 |
| 2023 | 4 | 73 | 1 (1) | 391 |
| 2024 | 4 | 148 | 0 | 511 |
| 2025 | 2 | — | 0 | 656 |
| 2026 | 3 | 85 | 24 (4) | — |
What is it indicated for?
Biosensors flow-directed Thermodilution catheters are designed for use in critical care patients to measure cardiac output, right atrium, pulmonary artery and pulmonary capillary wedge pressures; continuously monitor pulmonary artery temperature, sample blood, intravenously administer drugs and solution and measure cardiac output via the cardiac output computers which interface with 14 kilo-ohms catheters. Different models are available for use in…
Read the full statement (103 words)
Biosensors flow-directed Thermodilution catheters are designed for use in critical care patients to measure cardiac output, right atrium, pulmonary artery and pulmonary capillary wedge pressures; continuously monitor pulmonary artery temperature, sample blood, intravenously administer drugs and solution and measure cardiac output via the cardiac output computers which interface with 14 kilo-ohms catheters. Different models are available for use in pediatric and adult patients.
The tips of the catheters are mounted with a latex balloon which when inflated, protects the heart tissues from the product’s tips during insertion; utilizes blood flow to direct the catheter tip through the right ventricle into the pulmonary artery.
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/K083384 · printed Nov 5, 2026
Cite this page
510(k) Report. “K083384: Thermodilution Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K083384
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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