510(k) Report

510(k) · Cleared

Cleared

Cardiocap II Monitors: CH, CH-2, CH-S, CH-2S

K902492510(k) TraditionalCleared Jul 6, 199031-day reviewClass I21 CFR 870.2620

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

Datex Division Instrumentarium Corp. · DRI Monitor, Line Isolation

Cleared on Jul 6, 1990 after a 31-day review. FDA has not posted a summary or statement for it, so its predicates are not known.

Decided
Jul 6, 1990
Review
31 days
Class
Class I
Product code
DRI
Recalls
None
Predicates
0

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

FIG. 1 — Lineage of K902492Source: FDA 510(k) database · 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 DRI? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

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  • 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?

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.

How does its category compare?

All DRI devices

DRI Monitor, Line Isolation: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · DRI

FDA has decided no DRI device since 2007.

Median 510(k) review, days · DRI

Too few DRI 510(k)s in any year since 2007 to give a median.

Recalls per year · DRI

No recall names DRI since 2007.

Adverse event reports per year · DRI

1in 2019

2009: 12010: 12012: 12017: 12019: 1
2007high 1 (2009) · low 0 (2007)2025

MAUDE reports naming product code DRI, 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
20070—00
20080—00
20090—01
20100—01
20110—00
20120—01
20130—00
20140—00
20150—00
20160—00
20170—01
20180—00
20190—01
20200—00
20210—00
20220—00
20230—00
20240—00
20250—00
20260—0—

More from Datex Division Instrumentarium Corp.

55 FDA decisions under this applicant name. See the company

  • K953175AS/3 Estpr ModuleDatex Division Instrumentarium Corp. · 1997
  • K961247AS/3 Light MonitorDatex Division Instrumentarium Corp. · 1996
  • K943458AS/3 Airway ModuleDatex Division Instrumentarium Corp. · 1995
  • K945234AS/3 Memory Module, M0MEMDatex Division Instrumentarium Corp. · 1995
  • K933156Datex as/3 Patient MonitorDatex Division Instrumentarium Corp. · 1994

Recent decisions in DRI

The DRI category page

  • K902493Cardiocap II CG-2GS, 2G, 1GS, 1G, 2CG, CS MonitorDatex Division Instrumentarium Corp. · 1990
  • K822316Heart Monitor Bracelet AlarmHmba · 1982
  • K802326Pressure Monitoring LinesStanco Medical, Inc. · 1980

https://510kreport.com/device/K902492 · printed Nov 5, 2026

Cite this page

510(k) Report. “K902492: Cardiocap II Monitors: CH, CH-2, CH-S, CH-2S.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K902492

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