Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
IMB · Predicate Candidate Screening
5 FDA 510(k) clearances under this product code; the 50 most recent screened below.
144 daysmedian FDA review time
682 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K003916 | DERMALIFE HYDROFUSION SKIN & BODY CARE SYSTEM | Scandia Manufacturing , Ltd. | 2002-04-15 | 482 | 5 |
| K955808 | DYNA T-2000 PHYSICAL THERAPY SYSTEM | Thermia, Inc. | 1997-11-03 | 682 | 0 |
| K914234 | SAUNETTE, PORTABLE STEAM CABIN | Sauna Magic, Inc. | 1992-02-11 | 144 | 0 |
| K810320 | HEATPAC | Shinsei Corp. | 1981-03-04 | 26 | 0 |
| K770086 | SANAR | Health Improvement Assoc. | 1977-04-18 | 94 | 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