510(k) Report

510(k) · Cleared

Cleared

Cco System Model SP1467,SP5567,SP6267

K892941510(k) TraditionalCleared Nov 6, 1989199-day reviewClass II21 CFR 870.1915

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

Spectramed, Inc. · KRB Probe, Thermodilution

Cleared on Nov 6, 1989 after a 199-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 2 later devices descend from it.

Decided
Nov 6, 1989
Review
199 days
Class
Class II
Product code
KRB
Recalls
None
Predicates
0

2 later devices descend from it, 1 citing it directly.

Descendants, by year cleared 2000: 1 descendant cleared2002: 1 descendant cleared1990200020102020
  1. This deviceK892941 Cco System Model SP1467,SP5567,SP6267Spectramed, Inc. · 1989
  2. Descendant · cites it directly · 1 of its ownK991886 Pulsion Pulsiocath, Pulsion Pcco Monitoring Kit, Pulsion in-Line…Pulsion Medical Systems, Inc. · 2000 · Recalled
  3. Descendant · 2 generations on · 0 of its ownK020587 Pulsion Pulsiocath Picco Monitoring Kit, Injectate Sensor…Pulsion Medical Systems AG · 2002

Most influential descendants

Showing 2 of 2 · See all
  • K991886Pulsion Pulsiocath, Pulsion Pcco Monitoring Kit, Pulsion in-Line Injectate SensorPulsion Medical Systems, Inc. · 2000 · cites it directly1descendant
  • K020587Pulsion Pulsiocath Picco Monitoring Kit, Injectate Sensor Temperature Housing PV 4046Pulsion Medical Systems AG · 2002 · 2 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K892941Cco System Model SP1467,SP5567,SP6267Spectramed, Inc.1989—
+1K991886Pulsion Pulsiocath, Pulsion Pcco Monitoring Kit, Pulsion in-Line Injectate…Pulsion Medical Systems, Inc.20001
+2K020587Pulsion Pulsiocath Picco Monitoring Kit, Injectate Sensor Temperature Housing…Pulsion Medical Systems AG2002—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200010
200210
FIG. 1 — Lineage of K892941, 1989–2002Source: 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), 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
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What was it cleared against?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (2)

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

NumberDeviceApplicantDecidedDescendants
K991886Pulsion Pulsiocath, Pulsion Pcco Monitoring Kit, Pulsion in-Line Injectate SensorPulsion Medical Systems, Inc.20001

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, K991886 (Pulsion Medical Systems, Inc., 2000) has gone furthest, with 1 descendant of its own.

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—

More from Spectramed, Inc.

13 FDA decisions under this applicant name. See the company

  • K896122Amnicathdl (TM) DT-IUPC2 Dual Lumen Trans. TippedSpectramed, Inc. · 1990
  • K895323Model DT-Bal, Balance SaverSpectramed, Inc. · 1989
  • K894362Model DT-IUPC2 Transducer Tipped Dual Lumen IupSpectramed, Inc. · 1989
  • K881857Amnicath (TM) Model DT-Iupc Trans. Tipped Intrau.Spectramed, Inc. · 1989
  • K885235Safe-Draw (TM) Blood Sampling Reservoir & Access.Spectramed, Inc. · 19891 recall

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
  • K991886Pulsion Pulsiocath, Pulsion Pcco Monitoring Kit, Pulsion in-Line Injectate SensorPulsion Medical Systems, Inc. · 20001 recall

https://510kreport.com/device/K892941 · printed Nov 6, 2026

Cite this page

510(k) Report. “K892941: Cco System Model SP1467,SP5567,SP6267.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K892941

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Record history
  • FDA decision record loaded May 2, 2026
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026