Cleared Traditional

DELTAWAVE Nasal Pillows System (K233415) - FDA 510(k) Clearance

Class II Anesthesiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

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

Submission Details

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.

Device Classification

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 130
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)
K233829 · Fisher and Paykel Healthcare Limited · Aug 2024
AF531 Oro-Nasal EE Leak 1 Face Mask
K233555 · Philips Respironics · Jul 2024
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