Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
MLW · Predicate Candidate Screening
6 FDA 510(k) clearances under this product code; the 50 most recent screened below.
218 daysmedian FDA review time
445 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K240447 | ThermoChem HT-2000 System and Intraperitoneal Hyperthermia ( | Thermasolutions, LLC | 2025-05-05 | 445 | 0 |
| K131583 | THERMOCHEM HT-2000 | Thermasolutions, Inc. | 2013-10-03 | 125 | 0 |
| K020542 | DAYTRIPPER DIALYSATE WARMER | Stickman Industries, Inc. | 2002-09-27 | 220 | 0 |
| K993330 | THERMOCHEM-HT SYSTEM | Hemocleanse, Inc. | 1999-12-30 | 87 | 0 |
| K964825 | FREEDOM TRAVELLER | Impact Case Technologies, Inc. | 1997-05-19 | 168 | 0 |
| K933619 | PD-PAK | General Medical Mfg. Co. | 1994-02-22 | 218 | 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