510(k) Report

510(k) · Cleared

Cleared

Cariel F12

K823934510(k) TraditionalCleared Dec 16, 1983352-day reviewClass II21 CFR 870.2400

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

Odam · DYC Vectorcardiograph

Cleared on Dec 16, 1983 after a 352-day review. FDA has not posted a summary or statement for it, so its predicates are not known.

Decided
Dec 16, 1983
Review
352 days
Class
Class II
Product code
DYC
Recalls
None
Predicates
0

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

FIG. 1 — Lineage of K823934Source: 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 DYC devices

DYC Vectorcardiograph: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · DYC

FDA has decided no DYC device since 2007.

Median 510(k) review, days · DYC

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

Recalls per year · DYC

No recall names DYC since 2007.

Adverse event reports per year · DYC

No MAUDE report names DYC since 2007.

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—00
20200—00
20210—00
20220—00
20230—00
20240—00
20250—00
20260—0—

More from Odam

6 FDA decisions under this applicant name. See the company

Recent decisions in DYC

The DYC category page

  • K023414Mida Algorithm Rev. BOrtivus AB · 2003
  • K896396Mida System, Models 1000/1100Medical Graphics Corp. · 1990
  • K810529Direct Writing VectorcardiographElmed, Inc. · 1981

https://510kreport.com/device/K823934 · printed Nov 4, 2026

Cite this page

510(k) Report. “K823934: Cariel F12.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K823934

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