Cleared Traditional

K233415 - DELTAWAVE Nasal Pillows System

K233415 is an FDA 510(k) clearance for DELTAWAVE Nasal Pillows System, manufactured by Remsleep Holdings. The device is a Class 2 Anesthesiology device with product code BZD cleared through the Traditional 510(k) pathway after a 266-day FDA review.

K233415 · Remsleep Holdings · Anesthesiology device
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Jul 2024
Decision
266d
Days
Class 2
Risk

K233415 is an FDA 510(k) clearance for the DELTAWAVE Nasal Pillows System. Classified as Ventilator, Non-continuous (respirator) (product code BZD), Class II - Special Controls.

Submitted by Remsleep Holdings (Clearwater, US). The FDA issued a Cleared decision on July 2, 2024 after a review of 266 days - an extended review cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5905 - the FDA anesthesiology and respiratory device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Anesthesiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Remsleep Holdings devices

FDA 510(k) Submission Details - K233415

510(k) Number K233415 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 10, 2023
Decision Date July 02, 2024
Days to Decision 266 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
126d slower than avg
Panel avg: 140d · This submission: 266d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

BZD Device Classification - Class 2, Special Controls

Product Code BZD Ventilator, Non-continuous (respirator)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5905
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Anesthesiology devices follow this clearance model.

Regulatory Peers - BZD Ventilator, Non-continuous (respirator)

All 301
Devices cleared under the same product code (BZD) and FDA review panel - the closest regulatory comparables to K233415.
Nova Micro Pillows Mask Small A Model (NVP1SA)
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AF531 Oro-Nasal EE Leak 1 Face Mask
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Mojo 2 Full Face Vented Mask
K241661 · Sleepnet Corporation · Jul 2024
iQ 2 Nasal Vented Mask
K241469 · Sleepnet Corporation · Jun 2024
Oran Park Mask
K230476 · Resmed Pty Ltd (Registration Number: 3004604967) · Oct 2023
Therapy Mask 3100 NC/SP
K231313 · Respironics, Inc. · Jul 2023