Faxitron Bioptics, LLC: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Faxitron Bioptics, LLC” (first 2012, latest 2019), across 1 product code in 1 review panel. Median 510(k) review time under this name: 121 days. Since 2017 the median was 124 days, against 104 days for all cleared 510(k)s in the same product codes. 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 | 1 | 47 |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 1 | 108 |
| 2017 | 1 | 124 |
| 2018 | 1 | 203 |
| 2019 | 1 | 121 |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Faxitron Bioptics, LLC took a median 124 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 104 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| MWP | Cabinet, X-Ray System | 5 | 5 |
Review panels
- Radiology (5)
Most recent Faxitron Bioptics, LLC 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K183142 | PathVisionXL | MWP | 2019-03-14 | 121 |
| K173309 | Faxitron VisionCT | MWP | 2018-05-09 | 203 |
| K170786 | Faxitron Bioptics Speciemen Radiography System | MWP | 2017-07-18 | 124 |
| K153583 | BioVision Plus | MWP | 2016-04-01 | 108 |
| K122428 | FAXITRON SPECIEN RADIOGRAPHY SYSTEM | MWP | 2012-09-25 | 47 |
Recalls
openFDA lists no recalls under a recalling firm named Faxitron Bioptics, LLC.
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.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Faxitron X-Ray Corp. (2 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Faxitron Bioptics, LLC?
FDA lists 5 510(k) clearances under the applicant name “Faxitron Bioptics, LLC” (first 2012, latest 2019), across 1 product code in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Faxitron Bioptics, LLC?
The median time from FDA receipt to decision across 510(k)s cleared under the name Faxitron Bioptics, LLC is 121 days. Since 2017: 124 days, versus 104 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Faxitron Bioptics, LLC?
The most frequent FDA product codes under this applicant name are MWP (Cabinet, X-Ray System, 5).
Next steps
- See all 5 Faxitron Bioptics, LLC clearances with predicates and recalls
- Run predicate analysis for product code MWP, Faxitron Bioptics, LLC'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.