Vysis: FDA filings under this applicant name
FDA lists 8 510(k) clearances under the applicant name “Vysis” (first 1996, latest 2004), plus 1 De Novo decision, across 5 product codes in 2 review panels. Median 510(k) review time under this name: 126 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| MMW | System, Test, Tumor Marker, Monitoring, Bladder | 3 | 3 |
| OYU | Dna-Probe Kit, Human Chromosome | 3 | 3 |
| NTH | System, Automated Scanning Microscope And Image Analysis For Fluorescence In Situ Hybridization (Fish) Assays | 1 | 0 |
| OVQ | Chronic Lymphocytic Leukemia Fish Probe Kit | 1 | 1 |
| OXP | Dna-Probe Kit, Human Chromosome X And Y, Bmt Engraftment | 1 | 1 |
Review panels
- Pathology (6)
- Immunology (3)
Most recent Vysis 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K033982 | MODIFICATION TO VYSIS UROVYSION BLADDER CANCER RECURRENCE TEST | MMW | 2004-01-22 | 30 |
| K013785 | UROVYSION BLADDER CANCER RECURRENCE KIT | MMW | 2002-02-08 | 86 |
| K011031 | VYSIS UROVYSION BLADDER CANCER RECURRENCE KIT | MMW | 2001-08-03 | 120 |
| K010288 | ANEUVYSION MULITICOLOR DNA PROBE KIT | OYU | 2001-04-13 | 72 |
| K972200 | ANEUVYSION | OYU | 1997-10-20 | 132 |
| K954214 | CEP X SPECTRUMORANGE\Y SPECTRUMGREEN DNA PROBE KIT | OXP | 1997-01-21 | 502 |
| K962873 | CEP 12 SPECTRUMORANGE DIRECT LABELED CHROMOSOME ENUMERATION DNA PROBE | OVQ | 1997-01-13 | 174 |
| K953591 | CEP 8 SPECTRUMORANGE DNA PROBE KIT | OYU | 1996-11-29 | 486 |
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| DEN040010 | De Novo | System, Automated Scanning Microscope And Image Analysis For Fluorescence In Situ Hybridization (Fish) Assays | 2004-12-13 |
Recalls
1 product recalls in 1 recall events; 0 initiated in the last five years. Most recent: 2004-02-19.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Frequently asked questions
How many FDA 510(k) clearances are listed under Vysis?
FDA lists 8 510(k) clearances under the applicant name “Vysis” (first 1996, latest 2004), plus 1 De Novo decision, across 5 product codes in 2 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Vysis?
The median time from FDA receipt to decision across 510(k)s cleared under the name Vysis is 126 days.
Which FDA product codes appear under Vysis?
The most frequent FDA product codes under this applicant name are MMW (System, Test, Tumor Marker, Monitoring, Bladder, 3); OYU (Dna-Probe Kit, Human Chromosome, 3); NTH (System, Automated Scanning Microscope And Image Analysis For Fluorescence In Situ Hybridization (Fish) Assays, 1).
Next steps
- See all 8 Vysis clearances with predicates and recalls
- Run predicate analysis for product code MMW, Vysis's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.