Pennwalt Corp.: FDA clearances and approvals
Pennwalt Corp. has 6 FDA 510(k) clearances (first 1978, latest 1983), across 5 product codes in 3 review panels. Median 510(k) review time: 50 days.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| EAP | Unit, X-Ray, Intraoral | 2 | 2 |
| BXX | Calibrator, Pressure, Gas | 1 | 1 |
| EBC | Sealant, Pit And Fissure, And Conditioner | 1 | 1 |
| EHD | Unit, X-Ray, Extraoral With Timer | 1 | 1 |
| EJK | Liner, Cavity, Calcium Hydroxide | 1 | 1 |
Review panels
- Radiology (3)
- Dental (2)
- Anesthesiology (1)
Most recent Pennwalt Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K833241 | INTREX | EAP | 1983-10-28 | 67 |
| K801860 | S.S. WHITE-PENNWALT RENEW CALCIUM HYDROX | EJK | 1980-10-10 | 66 |
| K801274 | S.S. WHITE-PENNWALT PRELUDE PIT SEALANT | EBC | 1980-06-09 | 11 |
| K800133 | PANOREX II DENTAL X-RAY UNIT | EHD | 1980-03-03 | 42 |
| K800063 | XR-710 | EAP | 1980-03-03 | 52 |
| K780981 | PORTABLE PNEUMATIC CALIBRATOR 65-150 | BXX | 1978-08-02 | 49 |
Recalls
openFDA lists no recalls under a recalling firm named Pennwalt Corp..
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 Pennwalt Corp. have?
Pennwalt Corp. has 6 FDA 510(k) clearances (first 1978, latest 1983), across 5 product codes in 3 review panels.
How long does FDA take to clear Pennwalt Corp.'s 510(k)s?
The median time from FDA receipt to decision across Pennwalt Corp.'s cleared 510(k)s is 50 days.
What devices does Pennwalt Corp. make?
Its most frequent FDA product codes are EAP (Unit, X-Ray, Intraoral, 2); BXX (Calibrator, Pressure, Gas, 1); EBC (Sealant, Pit And Fissure, And Conditioner, 1).
Has Pennwalt Corp. had device recalls?
openFDA lists no recalls under a recalling firm name matching Pennwalt Corp. Related entities may recall under other names.
Next steps
- See all 6 Pennwalt Corp. clearances with predicates and recalls
- Run predicate analysis for product code EAP, Pennwalt Corp.'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.