510(k) · Cleared
ClearedPulsion Pulsiocath Picco Monitoring Kit, Injectate Sensor Temperature Housing PV 4046
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Pulsion Medical Systems AG · KRB Probe, Thermodilution
Cleared on May 23, 2002 as substantially equivalent to K991886 (Pulsion Medical Systems, Inc., 2000) after a 90-day review. Its family tree reaches back 2 generations to 1981. 1 of the 7 devices in its family, counting itself, has a Class I recall.
- Decided
- May 23, 2002
- Review
- 90 days
- Class
- Class II
- Product code
- KRB
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K810124 (1981). 6 ancestors in all. No later device cites it as a predicate yet. 1 of the 7 devices in this family, counting this one, has a Class I recall.
- Root · 2 generations backK810124 Swan-Ganz Vip Thermodilution CatheterAmerican Edwards Laboratories · 1981
- 1 generation backK991886 Pulsion Pulsiocath, Pulsion Pcco Monitoring Kit, Pulsion in-Line…Pulsion Medical Systems, Inc. · 2000 · Recalled
- This deviceK020587 Pulsion Pulsiocath Picco Monitoring Kit, Injectate Sensor…Pulsion Medical Systems AG · 2002
Class I recalls in this family
- K810675 Arrow Radial Artery Catheterization Set2 generations back · 1981
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K810124 | Swan-Ganz Vip Thermodilution Catheter | American Edwards Laboratories | 1981 | — |
| −1 | K991886 | Pulsion Pulsiocath, Pulsion Pcco Monitoring Kit, Pulsion in-Line Injectate… | Pulsion Medical Systems, Inc. | 2000 | 1 |
| 0 (this device) | K020587 | Pulsion Pulsiocath Picco Monitoring Kit, Injectate Sensor Temperature Housing… | Pulsion Medical Systems AG | 2002 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1981 | 1 | 1 |
| 1985 | 2 | 0 |
| 1989 | 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.
1 device in this family has a Class I recall. 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 |
|---|---|---|---|
| * | K991886 | Pulsion Pulsiocath, Pulsion Pcco Monitoring Kit, Pulsion in-Line Injectate SensorSummary page 1…ion Number Classification Name §870.1915 Probe, Thermodilution Predicate Devices The modified device is substantially equivalent to the device previously cleared under K991886. Modifications The primary modifications are changes to the injectate in-line sensor design, materials, and dimensions. Corresp… | 2000 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (1 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K810675Arrow Radial Artery Catheterization SetArrow Intl., Inc. · 1981 · 2 generations back · ◆ in the 1981 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 21 years and passes through 3 companies; a new generation was cleared every 19.3 years on median.
- 2 of the 6 ancestors have a recall of any class; 1 has a Class I recall.
How does its category compare?
All KRB devicesKRB Probe, Thermodilution: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · KRB
1in 2018
2026 to Oct 25, outlined.
Median 510(k) review, days · KRB
Too few KRB 510(k)s in any year since 2007 to give a median.
Recalls per year · KRB
3in 2018
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KRB
6in 2025
MAUDE reports naming product code KRB, 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 | 1 |
| 2008 | 0 | — | 0 | 2 |
| 2009 | 0 | — | 0 | 8 |
| 2010 | 1 | — | 0 | 2 |
| 2011 | 0 | — | 0 | 15 |
| 2012 | 0 | — | 0 | 20 |
| 2013 | 0 | — | 0 | 11 |
| 2014 | 0 | — | 0 | 14 |
| 2015 | 0 | — | 0 | 45 |
| 2016 | 0 | — | 0 | 25 |
| 2017 | 0 | — | 0 | 24 |
| 2018 | 1 | — | 3 | 18 |
| 2019 | 0 | — | 0 | 26 |
| 2020 | 0 | — | 0 | 16 |
| 2021 | 0 | — | 0 | 22 |
| 2022 | 0 | — | 0 | 21 |
| 2023 | 0 | — | 0 | 13 |
| 2024 | 0 | — | 0 | 33 |
| 2025 | 0 | — | 0 | 6 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The PULSION Pulsiocath Thermodilution Catheter and Pressure Monitoring Kit with Injectate In-Line Sensor are intended for use with the PULSION PiCCO Cardiac Output System for the measurement of cardiac output by the thermodilution method, measurement of arterial blood pressure, and for cardiac output determination by arterial pulse contour analysis. The PULSION PiCCO Cardiac Output System with Thermodilution Catheter and Pressure Monitoring Kit with…
Read the full statement (114 words)
The PULSION Pulsiocath Thermodilution Catheter and Pressure Monitoring Kit with Injectate In-Line Sensor are intended for use with the PULSION PiCCO Cardiac Output System for the measurement of cardiac output by the thermodilution method, measurement of arterial blood pressure, and for cardiac output determination by arterial pulse contour analysis. The PULSION PiCCO Cardiac Output System with Thermodilution Catheter and Pressure Monitoring Kit with Injectate In-Line Sensor is indicated in patients where cardiovascular and circulatory volume status monitoring is necessary. Such as patients in surgical, medical, cardiac, and burn specialty units as well as other specialty units where cardiovascular monitoring is desired and patients undergoing surgical interventions of such magnitude that cardiovascular monitoring is necessary.
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/K020587 · printed Nov 6, 2026
Cite this page
510(k) Report. “K020587: Pulsion Pulsiocath Picco Monitoring Kit, Injectate Sensor Temperature Housing PV 4046.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K020587
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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