Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Prism Enterprises, Inc. — Predicate Candidate Screening
4 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K030283 | BABY POD | Prism Enterprises, Inc. | 2003-04-22 | 85 | 0 |
| K020447 | MITYVAC MERLIN, MODEL 10027 | Prism Enterprises, Inc. | 2002-04-12 | 60 | 0 |
| K011532 | MITYVAC | Prism Enterprises, Inc. | 2001-07-30 | 73 | 4 |
| K000444 | MITYVIEW 4-WAY LATERAL EXPANDER SPECULUM | Prism Enterprises, Inc. | 2000-04-21 | 71 | 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