510(k) · Cleared
ClearedCardiac Output Kit, Model CO-1 & Inline Sensor Cable, Model Ils-1
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biosensors International-USA · DQO Catheter, Intravascular, Diagnostic
Cleared on Mar 12, 2003 as substantially equivalent to K830523 (Gould, Inc., 1983) after a 266-day review. Its family tree reaches back 1 generation to 1983.
- Decided
- Mar 12, 2003
- Review
- 266 days
- Class
- Class II
- Product code
- DQO
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K830523 (1983). No later device cites it as a predicate yet.
- Root · 1 generation backK830523 Catheter Connection W/Integral InjectateGould, Inc. · 1983
- This deviceK022004 Cardiac Output Kit, Model CO-1 & Inline Sensor Cable, Model Ils-1Biosensors International-USA · 2003
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K830523 | Catheter Connection W/Integral Injectate | Gould, Inc. | 1983 | — |
| 0 (this device) | K022004 | Cardiac Output Kit, Model CO-1 & Inline Sensor Cable, Model Ils-1 | Biosensors International-USA | 2003 | — |
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? (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 |
|---|---|---|---|
| * | K830523 | Catheter Connection W/Integral InjectateSummary page 1…t-term Intravascular Catheter and Accessories 4. Predicate Device(s): Becton Dickinson & Co. (B-D) (formerly Gould Inc. Oxnard, CA, K830523) SP4500 sterile In-line injectate system 5. Device Description: Biosensors Cardiac Output Kit is a sterile kit of disposab… | 1983 |
| * | — | Becton Dickinson’s sterile, package, disposable SP4572 system Named without a submission number | |
| * | — | Becton Dickinson’s CO Set and temperature probe Named without a submission number |
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?
- Its one ancestor has no recall.
How does its category compare?
All DQO devicesDQO Catheter, Intravascular, Diagnostic: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 Inline Sensor Assembly is designed for closed injectate delivery system use.
It connects to the CVP lumen of a Thermodilution catheter to perform room temperature
injections and determine a temperature reading. The inline temperature sensor housing
connects to a reusable thermistor cable assembly (the Inline Temperature Assembly) that
leads to a Marquette 7000 series Cardiac Output Computer. An inline check valve
prevents reflux of fluid andor blood into the system after injections. The intended use of
Biosensors Inline Sensor Assembly is identical to that of Becton Dickinson's SP4572
disposable in-line injectate set.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K022004 · printed Nov 6, 2026
Cite this page
510(k) Report. “K022004: Cardiac Output Kit, Model CO-1 & Inline Sensor Cable, Model Ils-1.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K022004
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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