510(k) Report

FDA applicant

Xtreem Pulse, LLC

New York, NY6 decisions2018–20260 recalls

FDA records 6 decisions for Xtreem Pulse, LLC (New York, NY) from 2018 to 2026: 6 510(k) clearances. Most are in product codes NFO (Stimulator, Transcutaneous Electrical…) and DRN (Device, Counter-Pulsating, External). Since 2016 its 510(k)s took a median of 112 days from receipt to decision, against 139 for FDA’s reviews in the same codes and years. Its devices cite 9 predicates, 4 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “Xtreem Pulse”.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, neurology panel, where it files most

How often FDA has decided Xtreem Pulse, LLC’s devices, and how often a recall has named them.

FDA decisions per year

1in 2025

2018: 12019: 12022: 12023: 12025: 12026 (partial year): 1
2018high 1 (2018) · low 0 (2020)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2018.

FIG. 1 — Xtreem Pulse, LLC by year, 2018–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Xtreem Pulse, LLC’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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Which product codes does it file in?

  • NFOStimulator, Transcutaneous Electrical, Aesthetic Purposes5decisions
  • DRNDevice, Counter-Pulsating, External1decision

How long do its 510(k) reviews take?

Since 2016, its 4 510(k)s took a median of 112 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 139 days; 3 of its 4 were faster than that.

Whose devices does it build on?

Its devices cite 9 predicates; 4 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 10 times; 4 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K221443PureLift Pro PlusXtreem Pulse, LLC · 20226cite it
  • K230506PureLift Pro EditionXtreem Pulse · 20231cites it
  • K243587PureLift GLOWXtreem Pulse, LLC · 20251cites it
  • K190269PureLiftXtreem Pulse, LLC · 20191cites it
  • K173483Pure Flow External Counter-Pulsation DeviceXtreem Pulse, LLC · 20181cites it

What has FDA decided for it lately?

  • K262861PureLift Pro MaxXtreem Pulse, LLC · 2026
  • K243587PureLift GLOWXtreem Pulse, LLC · 2025
  • K230506PureLift Pro EditionXtreem Pulse · 2023
  • K221443PureLift Pro PlusXtreem Pulse, LLC · 2022
  • K190269PureLiftXtreem Pulse, LLC · 2019
  • K173483Pure Flow External Counter-Pulsation DeviceXtreem Pulse, LLC · 2018

All 5 as Xtreem Pulse, LLC →The one decision as Xtreem Pulse →