510(k) · Cleared
ClearedAneuvysion
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Vysis · OYU Dna-Probe Kit, Human Chromosome
Cleared on Oct 20, 1997 after a 132-day review. The FDA summary names no predicate by number.
- Decided
- Oct 20, 1997
- Review
- 132 days
- Class
- Class II
- Product code
- OYU
- Recalls
- None
- Predicates
- 0
The FDA summary names no predicate by number.
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 OYU? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
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 OYU devicesOYU Dna-Probe Kit, Human Chromosome: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · OYU
FDA has decided no OYU device since 2007.
Median 510(k) review, days · OYU
Too few OYU 510(k)s in any year since 2007 to give a median.
Recalls per year · OYU
No recall names OYU since 2007.
Adverse event reports per year · OYU
1in 2024
MAUDE reports naming product code OYU, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 2 |
| 2023 | 0 | — | 0 | 1 |
| 2024 | 0 | — | 0 | 1 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The AneuVysion™ (CEP 18, X, Y-alpha satellite, LSI 13 and 21) Multicolor Probe Panel is intended to use CEP 18/X/Y probe to detect alpha satellite sequences in the centromere regions of chromosomes 18, X, and Y, and LSI 13/21 probe to detect the 13q14 region and the 21922.13 to 21q22.2 region. The AneuVysion™ kit is indicated for use as an adjunct to standard cytogenetic metaphase analysis for identifying and enumerating chrontosomes 13, 18, 21, X, and Y…
Read the full statement (240 words)
The AneuVysion™ (CEP 18, X, Y-alpha satellite, LSI 13 and 21) Multicolor Probe Panel is intended to use CEP 18/X/Y probe to detect alpha satellite sequences in the centromere regions of chromosomes 18, X, and Y, and LSI 13/21 probe to detect the 13q14 region and the 21922.13 to 21q22.2 region. The AneuVysion™ kit is indicated for use as an adjunct to standard cytogenetic metaphase analysis for identifying and enumerating chrontosomes 13, 18, 21, X, and Y via flucrescence in situ hybridization (FISH) in metaphase cells and interphase nuclei obtained from uncultured amniotic fluid in subjects with presumed high risk pregnancies. It is not intended to be used as a stand alone assay for test reporting. FISH results are intended to be reported and interpreted only in conjunction with results of standard cytogenetic analysis, performed concurrently, utilizing the same patient specimen. FISH results should not be re; prior to standard Cytogenetic results except in instances where reporting of FISH results alone is medically indicated or standard lf_::i\gngenetic results are not available, e.g., culture failure. Reporting and interpretafion of FISH should be consistent with professional standards of practice [1]. This device is intended for use only with amniocyte cells; it is not intended for and has not been validated for use with other test matrices. This FISH assay will not detect the presence of structural chromosome abnormalities frequently associated with birth defects. This FISH assay will be performed in cytogenetics laboratories.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K972200 · printed Nov 6, 2026
Cite this page
510(k) Report. “K972200: Aneuvysion.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K972200
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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