510(k) Report

510(k) · Cleared

Cleared

Cep X Spectrumorange\Y Spectrumgreen Dna Probe Kit

K954214510(k) TraditionalCleared Jan 21, 1997502-day reviewClass II21 CFR 866.6010

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

Vysis · OXP Dna-Probe Kit, Human Chromosome X And Y, Bmt Engraftment

Cleared on Jan 21, 1997 after a 502-day review. The FDA summary names no predicate by number.

Decided
Jan 21, 1997
Review
502 days
Class
Class II
Product code
OXP
Recalls
None
Predicates
0

The FDA summary names no predicate by number.

FIG. 1 — Lineage of K954214Source: 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), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in OXP? 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?

The FDA summary names no predicate by number.

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 OXP devices

OXP Dna-Probe Kit, Human Chromosome X And Y, Bmt Engraftment: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · OXP

FDA has decided no OXP device since 2007.

Median 510(k) review, days · OXP

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

Recalls per year · OXP

No recall names OXP since 2007.

Adverse event reports per year · OXP

No MAUDE report names OXP 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—

What is it indicated for?

This is designed to provide a reliable method for the simultaneous detection and enumeration of chromosomes X and Y in both interphase nuclei and metaphase spreads in bone marrow by fluorescence in situ hybridization (FISH).

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

More from Vysis

9 FDA decisions under this applicant name. See the company

  • DEN040010Vysis Autovysion SystemVysis · 2004
  • K033982Modification to Vysis Urovysion Bladder Cancer Recurrence TestVysis · 2004
  • K013785Urovysion Bladder Cancer Recurrence KitVysis · 20021 recall
  • K011031Vysis Urovysion Bladder Cancer Recurrence KitVysis · 20011 recall
  • K010288Aneuvysion Muliticolor Dna Probe KitVysis · 2001

https://510kreport.com/device/K954214 · printed Nov 6, 2026

Cite this page

510(k) Report. “K954214: Cep X Spectrumorange\Y Spectrumgreen Dna Probe Kit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K954214

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Record history
  • FDA decision record loaded May 2, 2026
  • Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
  • Page last updated Nov 3, 2026