510(k) · Cleared
ClearedPiCCO Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Pulsion Medical Systems SE · KRB Probe, Thermodilution
Cleared on Feb 21, 2018 as substantially equivalent to K072364 (Pulsion Medical Systems AG, 2007) after a 264-day review. Its family tree reaches back 1 generation to 2007.
- Decided
- Feb 21, 2018
- Review
- 264 days
- Class
- Class II
- Product code
- KRB
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K072364 (2007). No later device cites it as a predicate yet.
- Root · 1 generation backK072364 Pulsion Pulsiocath Thermodilution Catheters & AccessoriesPulsion Medical Systems AG · 2007
- This deviceK171620 PiCCO CatheterPulsion Medical Systems SE · 2018
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K072364 | Pulsion Pulsiocath Thermodilution Catheters & Accessories | Pulsion Medical Systems AG | 2007 | — |
| 0 (this device) | K171620 | PiCCO Catheter | Pulsion Medical Systems SE | 2018 | — |
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 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? (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 |
|---|---|---|---|
| * | K072364 | Pulsion Pulsiocath Thermodilution Catheters & AccessoriesSummary page 4…of the Federal Food, Drug and Cosmetic Act, the device classification is Class II, Product code KRB. Predicate Device: K072364 PULSION PULSIOCATH THERMODILUTION CATHETERS & ACCESSORIES… | 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?
- Its one ancestor has no recall.
- 1 other device also cites its predicate K072364.
How does its category compare?
All KRB devicesKRB Probe, Thermodilution: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, 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?
PiCCO Catheters are used as accessories for thermodilution and arterial blood pressure measurement.
PiCCO Catheters are 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 are undergoing surgical interventions of such magnitude that cardiovascular monitoring is necessary.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K171620 · printed Nov 6, 2026
Cite this page
510(k) Report. “K171620: PiCCO Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K171620
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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