Xenex Disinfection Services, Inc.: FDA clearances and approvals
Xenex Disinfection Services, Inc. has 0 FDA 510(k) clearances, plus 1 De Novo decision, across 1 product code in 1 review panel. openFDA lists 1 product recall by a recalling firm named Xenex Disinfection Services, Inc.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| QXJ | Whole Room Microbial Reduction Device | 1 | 0 |
Review panels
- General Hospital (1)
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| DEN230007 | De Novo | Whole Room Microbial Reduction Device | 2023-09-01 |
Recalls
1 product recalls in 1 recall events; 1 initiated in the last five years. Most recent: 2024-03-18.
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 Xenex Disinfection Services, Inc. have?
Xenex Disinfection Services, Inc. has 0 FDA 510(k) clearances, plus 1 De Novo decision, across 1 product code in 1 review panel.
What devices does Xenex Disinfection Services, Inc. make?
Its most frequent FDA product codes are QXJ (Whole Room Microbial Reduction Device, 1).
Has Xenex Disinfection Services, Inc. had device recalls?
openFDA lists 1 product recall in 1 recall event by a recalling firm whose name matches Xenex Disinfection Services, Inc; the most recent began 2024-03-18. Recall firm names are matched by name, so related entities filing under other names are not included.
Next steps
- See all 0 Xenex Disinfection Services, Inc. clearances with predicates and recalls
- Run predicate analysis for product code QXJ, Xenex Disinfection Services, 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.