Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
LSB · Predicate Candidate Screening
4 FDA 510(k) clearances under this product code; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K011768 | THERMO-THERAPY, MODELS TT-101, TT-201, AND TT-202 | Thermo-Electric Co. | 2001-08-03 | 57 | 0 |
| K011243 | CHATTANOOGA DRY HEAT WHIRLPOOL, MODEL 2000 | Chattanooga Group, Inc. | 2001-07-06 | 74 | 0 |
| K896817 | MODEL T11 FLUIDOTHERAPY UNIT | Henley Intl. | 1991-01-18 | 410 | 0 |
| K871802 | MODEL K210 AND K211 FLUIDOTHERAPY UNITS | Henley Intl. | 1987-09-04 | 119 | 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