510(k) Report

510(k) · Cleared

Recalled · Class II · 2014

Pulsion Pulsiocath, Pulsion Pcco Monitoring Kit, Pulsion in-Line Injectate Sensor

K991886510(k) TraditionalCleared May 11, 2000344-day reviewClass II21 CFR 870.1915Recalls 1

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Pulsion Medical Systems, Inc. · KRB Probe, Thermodilution

Cleared on May 11, 2000 as substantially equivalent to K810124 (American Edwards Laboratories, 1981) and 4 other predicates after a 344-day review. Its family tree reaches back 1 generation to 1981. 1 of the 7 devices in its family, counting itself, has a Class I recall. 1 later device descends from it. It has been recalled once.

Decided
May 11, 2000
Review
344 days
Class
Class II
Product code
KRB
Recalls
1
Predicates
5

Its longest line of descent runs back 1 generation to K810124 (1981). 5 ancestors in all. 1 later device descends from it, 1 citing it directly. 1 of the 7 devices in this family, counting this one, has a Class I recall.

Other ancestors, by year clearedDescendants, by year cleared 1989: 1 other ancestor1985: 2 other ancestors1981: 1 other ancestor, 1 with a Class I recall12002: 1 descendant clearedK810124 · Swan-Ganz Vip Thermodilution Catheter · American Edwards Laboratories · 198119801990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 4 other ancestors, 1 with a Class I recall1 1 generation forward: 1 descendant K810124 · Swan-Ganz Vip Thermodilution Catheter · American Edwards Laboratories · 19810
  1. Root · 1 generation backK810124 Swan-Ganz Vip Thermodilution CatheterAmerican Edwards Laboratories · 1981
  2. This deviceK991886 Pulsion Pulsiocath, Pulsion Pcco Monitoring Kit, Pulsion in-Line…Pulsion Medical Systems, Inc. · 2000
  3. Descendant · cites it directly · 0 of its ownK020587 Pulsion Pulsiocath Picco Monitoring Kit, Injectate Sensor…Pulsion Medical Systems AG · 2002

Class I recalls in this family

  • K810675 Arrow Radial Artery Catheterization Setdirect predicate · 1981

Most influential descendants

Showing 1 of 1 · See all
  • K020587Pulsion Pulsiocath Picco Monitoring Kit, Injectate Sensor Temperature Housing PV 4046Pulsion Medical Systems AG · 2002 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K810124Swan-Ganz Vip Thermodilution CatheterAmerican Edwards Laboratories1981—
0 (this device)K991886Pulsion Pulsiocath, Pulsion Pcco Monitoring Kit, Pulsion in-Line Injectate…Pulsion Medical Systems, Inc.2000—
+1K020587Pulsion Pulsiocath Picco Monitoring Kit, Injectate Sensor Temperature Housing…Pulsion Medical Systems AG2002—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198111
198520
198910

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200210
FIG. 1 — Lineage of K991886, 1981–2002Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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
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What was it cleared against? (5)

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.

TypeNumberDeviceApplicantDecidedRecalls
*K810124Swan-Ganz Vip Thermodilution Catheter
Summary page 1
…ion Pulsiocath Thermodilution Catheter and introducer accessories are substantially equivalent to the Baxter Swan-Ganz® VIP™ Thermodilution Catheter marketed pursuant to K810124, and the Arrow International Radial (Femoral) Artery Catheterization Set marketed under K810675. The Pulsion in-line injectate se…
American Edwards Laboratories1981—
*K810675Arrow Radial Artery Catheterization Set
Summary page 1
…o the Baxter Swan-Ganz® VIP™ Thermodilution Catheter marketed pursuant to K810124, and the Arrow International Radial (Femoral) Artery Catheterization Set marketed under K810675. The Pulsion in-line injectate sensor is substantially equivalent to that marketed by Spectramed under K892941. The Pulsion Pres…
Arrow Intl., Inc.1981Class I
*K892941Cco System Model SP1467,SP5567,SP6267
Summary page 1
…Radial (Femoral) Artery Catheterization Set marketed under K810675. The Pulsion in-line injectate sensor is substantially equivalent to that marketed by Spectramed under K892941. The Pulsion Pressure Monitoring Kit and Disposable Pressure Transducer are substantially equivalent to those sold by Utah Medic…
Spectramed, Inc.1989—
*K842352Pressure Monitoring Kit
Summary page 1
…Spectramed under K892941. The Pulsion Pressure Monitoring Kit and Disposable Pressure Transducer are substantially equivalent to those sold by Utah Medical pursuant to K842352 and K841788, respectively. 094 4. When coupled with the Pulsion Continuous Pulse Contour Cardiac Output System (…
Utah Medical Products, Inc.1985—
*K841788Utah Disposable Pressure Transducer
Summary page 1
…under K892941. The Pulsion Pressure Monitoring Kit and Disposable Pressure Transducer are substantially equivalent to those sold by Utah Medical pursuant to K842352 and K841788, respectively. 094 4. When coupled with the Pulsion Continuous Pulse Contour Cardiac Output System (PiCCO), the…
Utah Medical Products, Inc.1985—

Also cleared against K810124: 1 other device →

What descends from it? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K020587Pulsion Pulsiocath Picco Monitoring Kit, Injectate Sensor Temperature Housing PV 4046Pulsion Medical Systems AG20020

Has anything in its family been recalled? (1 Class I)

Recalls of this device

DateClassRecallRoot causeReason
Nov 4, 2014Class IIZ-1121-2015PackagingInternal testing and investigation of the packaging revealed cracks and holes in primary packaging

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 · Direct predicate · ◆ in the 1981 ancestors bar of FIG. 11 Class I recall

What does this lineage say?

  • 1 of the 5 ancestors has a recall of any class; 1 has a Class I recall.
  • Of its descendants, K020587 (Pulsion Medical Systems AG, 2002) has gone furthest, with 0 descendants of its own.
  • 1 other device also cites its predicate K810124.

How does its category compare?

All KRB devices

KRB Probe, Thermodilution: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · KRB

1in 2018

2007: 12010: 12018: 1
2007high 1 (2007) · low 0 (2008)2026

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

2018: 3
2007high 3 (2018) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · KRB

6in 2025

2007: 12008: 22009: 82010: 22011: 152012: 202013: 112014: 142015: 452016: 252017: 242018: 182019: 262020: 162021: 222022: 212023: 132024: 332025: 6
2007high 45 (2015) · low 1 (2007)2025

MAUDE reports naming product code KRB, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20071—01
20080—02
20090—08
20101—02
20110—015
20120—020
20130—011
20140—014
20150—045
20160—025
20170—024
20181—318
20190—026
20200—016
20210—022
20220—021
20230—013
20240—033
20250—06
20260—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.

Also cleared against K810124

1 other device cites the same predicate.

  • K160084Swan Ganz CathetersEdwards Lifesciences, LLC · 20164 Class I recalls

More from Pulsion Medical Systems, Inc.

3 FDA decisions under this applicant name. See the company

  • K112448PulsioflexPulsion Medical Systems, Inc. · 2011
  • K001762Pulsion Continuous Pulse Contour Cardiac Output (Picco) SystemPulsion Medical Systems, Inc. · 2000

Recent decisions in KRB

The KRB category page

  • K171620PiCCO CatheterPulsion Medical Systems SE · 2018
  • K100739Volumeview System, Models VLV520FT6R, VLV520FT8R, VLV520FT6R5Edwards Lifesciences, LLC · 2010
  • K072364Pulsion Pulsiocath Thermodilution Catheters & AccessoriesPulsion Medical Systems AG · 2007
  • K020587Pulsion Pulsiocath Picco Monitoring Kit, Injectate Sensor Temperature Housing PV 4046Pulsion Medical Systems AG · 2002
  • K936182Critikit Plus in Line Room/Ice Temperature Injectate KitOhmeda Medical · 1994

https://510kreport.com/device/K991886 · printed Nov 6, 2026

Cite this page

510(k) Report. “K991886: Pulsion Pulsiocath, Pulsion Pcco Monitoring Kit, Pulsion in-Line Injectate Sensor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K991886

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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