Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Life Enhancement Technologies, LLC · Predicate Candidate Screening
3 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K900356 | THERMOAIRE SPLINT (TM) (TAS) | Life Enhancement Technologies, LLC | 1990-05-07 | 102 | 0 |
| K900355 | MARK VII THERMOREGULATION ASSIST SYSTEM | Life Enhancement Technologies, LLC | 1990-02-15 | 21 | 0 |
| K873200 | KARLSON OZONE STERILIZER MODEL 100B | Life Enhancement Technologies, LLC | 1989-01-27 | 533 | 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