Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Xtreem Pulse, LLC — Predicate Candidate Screening
4 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K243587 | PureLift GLOW | Xtreem Pulse, LLC | 2025-03-06 | 106 | 0 |
| K221443 | PureLift Pro Plus | Xtreem Pulse, LLC | 2022-10-21 | 156 | 0 |
| K190269 | PureLift | Xtreem Pulse, LLC | 2019-08-28 | 201 | 0 |
| K173483 | Pure Flow External Counter-Pulsation Device | Xtreem Pulse, LLC | 2018-05-30 | 198 | 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