Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Thermedx, LLC — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
226 daysmedian FDA review time
388 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K210628 | X-FLO Fluid Management System | Thermedx, LLC | 2021-11-04 | 247 | 0 |
| K172048 | FluidSmart | Thermedx, LLC | 2017-09-05 | 61 | 1 |
| K133799 | THERMEDX FLUID MANAGMENT SYSTEM | Thermedx, LLC | 2014-06-20 | 189 | 2 |
| K102275 | THERMEDX 37-5 ELECTROCAUTERY PROBES, MODELS MPJ200, MPJ210, | Thermedx, LLC | 2011-03-25 | 226 | 0 |
| K091939 | THERMEDX PRODIGY FLUID MANAGEMENT SYSTEM, MODELS P1000, P200 | Thermedx, LLC | 2010-07-23 | 388 | 2 |
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