Xtreem Pulse, LLC: FDA clearances and approvals
Xtreem Pulse, LLC has 6 FDA 510(k) clearances (first 2018, latest 2026), across 2 product codes in 2 review panels. Median 510(k) review time: 136 days. Since 2017 its median was 136 days, against 156 days for all cleared 510(k)s in the same product codes.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2018 | 1 | 198 |
| 2019 | 1 | 201 |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 1 | 156 |
| 2023 | 1 | 117 |
| 2024 | 0 | — |
| 2025 | 1 | 106 |
| 2026 | 1 | 29 |
Review time against the same product codes
Since 2017, Xtreem Pulse, LLC's cleared 510(k)s took a median 136 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 156 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| NFO | Stimulator, Transcutaneous Electrical, Aesthetic Purposes | 5 | 5 |
| DRN | Device, Counter-Pulsating, External | 1 | 1 |
Review panels
- Neurology (5)
- Cardiovascular (1)
Most recent Xtreem Pulse, LLC 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K262861 | PureLift Pro Max | NFO | 2026-09-11 | 29 |
| K243587 | PureLift GLOW | NFO | 2025-03-06 | 106 |
| K230506 | PureLift Pro Edition | NFO | 2023-06-21 | 117 |
| K221443 | PureLift Pro Plus | NFO | 2022-10-21 | 156 |
| K190269 | PureLift | NFO | 2019-08-28 | 201 |
| K173483 | Pure Flow External Counter-Pulsation Device | DRN | 2018-05-30 | 198 |
Recalls
openFDA lists no recalls under a recalling firm named Xtreem Pulse, LLC.
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Xtreem Pulse, LLC have?
Xtreem Pulse, LLC has 6 FDA 510(k) clearances (first 2018, latest 2026), across 2 product codes in 2 review panels.
How long does FDA take to clear Xtreem Pulse, LLC's 510(k)s?
The median time from FDA receipt to decision across Xtreem Pulse, LLC's cleared 510(k)s is 136 days. Since 2017: 136 days, versus 156 days for all cleared 510(k)s in the same product codes.
What devices does Xtreem Pulse, LLC make?
Its most frequent FDA product codes are NFO (Stimulator, Transcutaneous Electrical, Aesthetic Purposes, 5); DRN (Device, Counter-Pulsating, External, 1).
Has Xtreem Pulse, LLC had device recalls?
openFDA lists no recalls under a recalling firm name matching Xtreem Pulse, LLC. Related entities may recall under other names.
Next steps
- See all 6 Xtreem Pulse, LLC clearances with predicates and recalls
- Run predicate analysis for product code NFO, Xtreem Pulse, LLC's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.