510(k) · Cleared
ClearedPulsion Pulsiocath Thermodilution Catheters & Accessories
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 Sep 19, 2007 after a 28-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 4 later devices descend from it.
- Decided
- Sep 19, 2007
- Review
- 28 days
- Class
- Class II
- Product code
- KRB
- Recalls
- None
- Predicates
- 0
4 later devices descend from it, 2 citing it directly.
- This deviceK072364 Pulsion Pulsiocath Thermodilution Catheters & AccessoriesPulsion Medical Systems AG · 2007
- Descendant · cites it directly · 2 of its ownK100739 Volumeview System, Models VLV520FT6R, VLV520FT8R, VLV520FT6R5Edwards Lifesciences, LLC · 2010
- Descendant · 2 generations on · 1 of its ownK110167 Presep Oligon Oximetry Catheters (16 CM, W/Heparin), (20CM, W/Heparin)Edwards Lifesciences, LLC · 2011
- Descendant · cites it directly · 0 of its ownK171620 PiCCO CatheterPulsion Medical Systems SE · 2018
- Descendant · 2 generations on · 0 of its ownK113565 Multi-Med Central Venous Catheters (CVCS), with and Without Heparin…Edwards Lifesciences, LLC · 2012
Most influential descendants
Showing 4 of 4 · See all- K100739Volumeview System, Models VLV520FT6R, VLV520FT8R, VLV520FT6R5Edwards Lifesciences, LLC · 2010 · cites it directly2descendants
- K110167Presep Oligon Oximetry Catheters (16 CM, W/Heparin), (20CM, W/Heparin)Edwards Lifesciences, LLC · 2011 · 2 generations on1descendant
- K171620PiCCO CatheterPulsion Medical Systems SE · 2018 · cites it directly0descendants
- K113565Multi-Med Central Venous Catheters (CVCS), with and Without Heparin Vantex Central…Edwards Lifesciences, LLC · 2012 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K072364 | Pulsion Pulsiocath Thermodilution Catheters & Accessories | Pulsion Medical Systems AG | 2007 | — |
| +1 | K100739 | Volumeview System, Models VLV520FT6R, VLV520FT8R, VLV520FT6R5 | Edwards Lifesciences, LLC | 2010 | — |
| +2 | K110167 | Presep Oligon Oximetry Catheters (16 CM, W/Heparin), (20CM, W/Heparin) | Edwards Lifesciences, LLC | 2011 | — |
| +1 | K171620 | PiCCO Catheter | Pulsion Medical Systems SE | 2018 | — |
| +2 | K113565 | Multi-Med Central Venous Catheters (CVCS), with and Without Heparin Vantex… | Edwards Lifesciences, LLC | 2012 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2018 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in KRB? 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?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (4)
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?
- Of its descendants, K100739 (Edwards Lifesciences, LLC, 2010) has gone furthest, with 2 descendants of its own.
How does its category compare?
All KRB devicesKRB Probe, Thermodilution: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.
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 bum 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 as stated in the FDA 510(k) statement.
https://510kreport.com/device/K072364 · printed Nov 4, 2026
Cite this page
510(k) Report. “K072364: Pulsion Pulsiocath Thermodilution Catheters & Accessories.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K072364
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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