510(k) Report

FDA applicant

Remsleep Holdings

Clearwater, FL2 decisions2024–20260 recalls

FDA records 2 decisions for Remsleep Holdings (Clearwater, FL) from 2024 to 2026: 2 510(k) clearances. All are in product code BZD (Ventilator, Non-Continuous (Respirator)). Its devices cite 2 predicates, 1 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “RemSleep Holdings, Inc.”.

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

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

How often FDA has decided Remsleep Holdings’s devices, and how often a recall has named them.

FDA decisions per year

1in 2024

2024: 12026 (partial year): 1
2024high 1 (2024) · low 0 (2025)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2024.

FIG. 1 — Remsleep Holdings by year, 2024–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • BZDVentilator, Non-Continuous (Respirator)2decisions

Whose devices does it build on?

Its devices cite 2 predicates; 1 are its own earlier devices. The firms it cites most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K233415DELTAWAVE Nasal Pillows SystemRemsleep Holdings · 20241cites it

What has FDA decided for it lately?

  • K253939DeltaWave Nasal Pillow SystemRemSleep Holdings, Inc. · 2026
  • K233415DELTAWAVE Nasal Pillows SystemRemsleep Holdings · 2024

The one decision as Remsleep Holdings →The one decision as RemSleep Holdings, Inc. →