Tripath Imaging, Inc.: FDA clearances and approvals
Tripath Imaging, Inc. has 5 FDA 510(k) clearances (first 2005, latest 2007), across 2 product codes in 1 review panel. Median 510(k) review time: 113 days. openFDA lists 24 product recalls by a recalling firm named Tripath Imaging, Inc.
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 |
|---|---|---|---|
| NQN | Microscope, Automated, Image Analysis, Immunohistochemistry,Operator Intervention,Nuclear Intensity & Percent Positivity | 4 | 4 |
| NOT | Microscope, Automated, Image Analysis, Operator Intervention | 1 | 1 |
Review panels
- Pathology (5)
Most recent Tripath Imaging, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K061613 | VENTANA IMAGE ANALYSIS SYSTEM - PATHWAY HER2 (4B5) | NQN | 2007-01-10 | 215 |
| K062428 | VENTANA IMAGE ANALYSIS SYSTEM, MODEL VIAS | NQN | 2006-09-29 | 42 |
| K053520 | VENTANA IMAGE ANALYSIS SYSTEM, MODEL KI-67 | NQN | 2006-04-11 | 113 |
| K051282 | VENTANA IMAGE ANALYSIS SYSTEM - HER2/NEU | NOT | 2005-08-16 | 91 |
| K050012 | VENTANA IMAGE ANALYSIS SYSTEM | NQN | 2005-05-06 | 123 |
Recalls
24 product recalls in 3 recall events; 0 initiated in the last five years. Most recent: 2012-03-22.
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Tripath Imaging, Inc. have?
Tripath Imaging, Inc. has 5 FDA 510(k) clearances (first 2005, latest 2007), across 2 product codes in 1 review panel.
How long does FDA take to clear Tripath Imaging, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Tripath Imaging, Inc.'s cleared 510(k)s is 113 days.
What devices does Tripath Imaging, Inc. make?
Its most frequent FDA product codes are NQN (Microscope, Automated, Image Analysis, Immunohistochemistry,Operator Intervention,Nuclear Intensity & Percent Positivity, 4); NOT (Microscope, Automated, Image Analysis, Operator Intervention, 1).
Has Tripath Imaging, Inc. had device recalls?
openFDA lists 24 product recalls in 3 recall events by a recalling firm whose name matches Tripath Imaging, Inc; the most recent began 2012-03-22. Recall firm names are matched by name, so related entities filing under other names are not included.
Next steps
- See all 5 Tripath Imaging, Inc. clearances with predicates and recalls
- Run predicate analysis for product code NQN, Tripath Imaging, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.