Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Delaware Prosthetics, Inc. — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
157 daysmedian FDA review time
167 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K832151 | PDM SILOXANE PROSTHETIC ORBIT | Delaware Prosthetics, Inc. | 1983-12-19 | 167 | 0 |
| K832152 | PDM SILOXANE PROSTHETIC EAR | Delaware Prosthetics, Inc. | 1983-12-09 | 157 | 0 |
| K832153 | PDM SILOXANE PROSTHETIC NOSE | Delaware Prosthetics, Inc. | 1983-12-09 | 157 | 0 |
| K832149 | PDM SILOXANE PROSTHETIC OBTURATOR | Delaware Prosthetics, Inc. | 1983-11-28 | 146 | 0 |
| K832148 | PDM SILOXANE PROSTHETIC CHIN IMPLANT | Delaware Prosthetics, Inc. | 1983-11-28 | 146 | 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