Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Prizm Medical, Inc. · Predicate Candidate Screening
8 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
330 daysmedian FDA review time
416 days90th percentile
8clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K133502 | 5000Z FIREFLY SYSTEM | Prizm Medical, Inc. | 2014-12-03 | 384 | 0 |
| K033122 | 5000Z SYSTEM (OTC) | Prizm Medical, Inc. | 2004-08-25 | 330 | 0 |
| K032239 | THERA-CREAM, MODEL TCT004 | Prizm Medical, Inc. | 2004-07-30 | 375 | 0 |
| K024181 | PRIZM MEDICAL, INC. MICRO-Z STIMULATION SYSTEM | Prizm Medical, Inc. | 2003-06-26 | 189 | 0 |
| K012974 | PRIZM MEDICAL INC. THERMOTRACE INFRARED THERMOMETER MODELS 1 | Prizm Medical, Inc. | 2002-07-23 | 321 | 0 |
| K951727 | Z-WATCH SYSTEM | Prizm Medical, Inc. | 1995-11-21 | 222 | 0 |
| K944487 | ELECTRO-MESH SOCK, WRAP, AND SLEEVE ELECTRODES | Prizm Medical, Inc. | 1995-02-21 | 161 | 0 |
| K932299 | ELECTRO-MESH | Prizm Medical, Inc. | 1994-07-01 | 416 | 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