Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Faxitron Bioptics, LLC — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
121 daysmedian FDA review time
203 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K183142 | PathVisionXL | Faxitron Bioptics, LLC | 2019-03-14 | 121 | 0 |
| K173309 | Faxitron VisionCT | Faxitron Bioptics, LLC | 2018-05-09 | 203 | 0 |
| K170786 | Faxitron Bioptics Speciemen Radiography System | Faxitron Bioptics, LLC | 2017-07-18 | 124 | 0 |
| K153583 | BioVision Plus | Faxitron Bioptics, LLC | 2016-04-01 | 108 | 0 |
| K122428 | FAXITRON SPECIEN RADIOGRAPHY SYSTEM | Faxitron Bioptics, LLC | 2012-09-25 | 47 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda