Timpel, Inc.: FDA clearances and approvals
Timpel, 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 |
|---|---|---|---|
| QEB | Ventilatory Electrical Impedance Tomograph | 1 | 0 |
Review panels
- Anesthesiology (1)
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| DEN170072 | De Novo | Ventilatory Electrical Impedance Tomograph | 2018-12-20 |
Recalls
openFDA lists no recalls under a recalling firm named Timpel, 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 Timpel, Inc. have?
Timpel, Inc. has 0 FDA 510(k) clearances, plus 1 De Novo decision, across 1 product code in 1 review panel.
What devices does Timpel, Inc. make?
Its most frequent FDA product codes are QEB (Ventilatory Electrical Impedance Tomograph, 1).
Has Timpel, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Timpel, Inc. Related entities may recall under other names.
Next steps
- See all 0 Timpel, Inc. clearances with predicates and recalls
- Run predicate analysis for product code QEB, Timpel, 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.