510(k) Report

510(k) · Cleared

Cleared

Centurion Cardiac Detector

K832828510(k) TraditionalCleared May 9, 1984264-day reviewClass I21 CFR 870.2600

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

Clinical Data Instruments, Inc. · DRJ System, Signal Isolation

Cleared on May 9, 1984 after a 264-day review. FDA has not posted a summary or statement for it, so its predicates are not known.

Decided
May 9, 1984
Review
264 days
Class
Class I
Product code
DRJ
Recalls
None
Predicates
0

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

FIG. 1 — Lineage of K832828Source: 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.

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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 DRJ devices

DRJ System, Signal Isolation: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · DRJ

FDA has decided no DRJ device since 2007.

Median 510(k) review, days · DRJ

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

Recalls per year · DRJ

No recall names DRJ since 2007.

Adverse event reports per year · DRJ

3in 2025

2019: 42020: 72021: 32022: 42023: 32024: 22025: 3
2007high 7 (2020) · low 0 (2007)2025

MAUDE reports naming product code DRJ, 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—00
20100—00
20110—00
20120—00
20130—00
20140—00
20150—00
20160—00
20170—00
20180—00
20190—04
20200—07
20210—03
20220—04
20230—03
20240—02
20250—03
20260—0—

More from Clinical Data Instruments, Inc.

3 FDA decisions under this applicant name. See the company

  • K842349Ambulatory PH Recording DeviceClinical Data Instruments, Inc. · 1985
  • K832829Neo-Float Neonatal Flotation Sys & RhytClinical Data Instruments, Inc. · 1983

Recent decisions in DRJ

The DRJ category page

  • K822590Pressure Isolation Amplifier #9813 517Honeywell, Inc. · 1982
  • K771685Amplifier Model N5A-HisHoneywell, Inc. · 1977
  • K771684Amplifier Model N5A-EcgHoneywell, Inc. · 1977

https://510kreport.com/device/K832828 · printed Nov 6, 2026

Cite this page

510(k) Report. “K832828: Centurion Cardiac Detector.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K832828

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