Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Prism Technologies, Inc. — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
106 daysmedian FDA review time
169 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K980212 | MITYVAC | Prism Technologies, Inc. | 1998-07-09 | 169 | 0 |
| K953542 | COLDGEL | Prism Technologies, Inc. | 1995-10-30 | 94 | 0 |
| K953541 | INSTANT COLDGEL | Prism Technologies, Inc. | 1995-10-05 | 69 | 0 |
| K934631 | TRANSWARMER | Prism Technologies, Inc. | 1994-02-03 | 132 | 1 |
| K912715 | INSTANT WARM GEL PACK | Prism Technologies, Inc. | 1991-10-02 | 106 | 4 |
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