510(k) Report

510(k) · Cleared

Cleared

Cetus CMV Iha

K822965510(k) TraditionalCleared Feb 15, 1983131-day reviewClass II21 CFR 866.3175

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

Cetus Corp. · LJO Antigen, Iha, Cytomegalovirus

Cleared on Feb 15, 1983 after a 131-day review. FDA has not posted a summary or statement for it, so its predicates are not known.

Decided
Feb 15, 1983
Review
131 days
Class
Class II
Product code
LJO
Recalls
None
Predicates
0

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

FIG. 1 — Lineage of K822965Source: 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 LJO? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new LJO device

  1. #1 K203612 Capture-CMVscore 1.3 · 2 generations · no Class I recall
Get a 510(k) Report

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 LJO devices

LJO Antigen, Iha, Cytomegalovirus: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · LJO

1in 2021

2019: 12021: 1
2007high 1 (2019) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · LJO

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

Recalls per year · LJO

No recall names LJO since 2007.

Adverse event reports per year · LJO

1in 2018

2011: 22016: 12018: 1
2007high 2 (2011) · low 0 (2007)2025

MAUDE reports naming product code LJO, 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—02
20120—00
20130—00
20140—00
20150—00
20160—01
20170—00
20180—01
20191—00
20200—00
20211—00
20220—00
20230—00
20240—00
20250—00
20260—0—

More from Cetus Corp.

3 FDA decisions under this applicant name. See the company

  • K861580Progroup (TM) Automated Liquid Handling SystemCetus Corp. · 1986
  • K844968Epichrome PapCetus Corp. · 1985

Recent decisions in LJO

The LJO category page

  • K203612Capture-CMVImmucor, Inc. · 2021
  • K183571Capture-CMVImmucor, Inc. · 2019
  • K001767Diamedix IS-CMV Igm Capture Test SystemDiamedix Corp. · 2000
  • K974901Hybrid Capture System CMV Dna AssayDigene Corp. · 1998
  • K974456CmvgenInstrumentation Laboratory CO · 1998

https://510kreport.com/device/K822965 · printed Nov 6, 2026

Cite this page

510(k) Report. “K822965: Cetus CMV Iha.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K822965

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