Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Pennwalt Corp. — Predicate Candidate Screening
6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
52 daysmedian FDA review time
67 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K833241 | INTREX | Pennwalt Corp. | 1983-10-28 | 67 | 0 |
| K801860 | S.S. WHITE-PENNWALT RENEW CALCIUM HYDROX | Pennwalt Corp. | 1980-10-10 | 66 | 0 |
| K801274 | S.S. WHITE-PENNWALT PRELUDE PIT SEALANT | Pennwalt Corp. | 1980-06-09 | 11 | 0 |
| K800133 | PANOREX II DENTAL X-RAY UNIT | Pennwalt Corp. | 1980-03-03 | 42 | 0 |
| K800063 | XR-710 | Pennwalt Corp. | 1980-03-03 | 52 | 0 |
| K780981 | PORTABLE PNEUMATIC CALIBRATOR 65-150 | Pennwalt Corp. | 1978-08-02 | 49 | 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