RQMIS, Inc.: FDA clearances and approvals
RQMIS, Inc. has 0 FDA 510(k) clearances, plus 1 De Novo decision, across 1 product code in 1 review panel.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| QTH | Endoscopic Light-Projecting Measuring Device | 1 | 0 |
Review panels
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| DEN210032 | De Novo | Endoscopic Light-Projecting Measuring Device | 2022-07-26 |
Recalls
openFDA lists no recalls under a recalling firm named RQMIS, Inc..
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 RQMIS, Inc. have?
RQMIS, Inc. has 0 FDA 510(k) clearances, plus 1 De Novo decision, across 1 product code in 1 review panel.
What devices does RQMIS, Inc. make?
Its most frequent FDA product codes are QTH (Endoscopic Light-Projecting Measuring Device, 1).
Has RQMIS, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching RQMIS, Inc. Related entities may recall under other names.
Next steps
- See all 0 RQMIS, Inc. clearances with predicates and recalls
- Run predicate analysis for product code QTH, RQMIS, 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.