Cleared Traditional

NASAL JACKS MASK (K032433) - FDA 510(k) Clearance

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

K032433 · Resmed, Ltd. · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2003
Decision
79d
Days
Class 2
Risk

K032433 is an FDA 510(k) clearance for the NASAL JACKS MASK. Classified as Ventilator, Non-continuous (respirator) (product code BZD), Class II - Special Controls.

Submitted by Resmed, Ltd. (Poway, US). The FDA issued a Cleared decision on October 24, 2003 after a review of 79 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Resmed, Ltd. devices

Submission Details

510(k) Number K032433 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 06, 2003
Decision Date October 24, 2003
Days to Decision 79 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
60d faster than avg
Panel avg: 139d · This submission: 79d
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 459
Devices cleared under the same product code (BZD) and FDA review panel - the closest regulatory comparables to K032433.
Orion
K253553 · ResMed Corp · Jun 2026
ResScan Essentials
K254104 · ResMed Corp · May 2026
Sleep Apnea Breathing Therapy Mask:JoyMask 20-B Full Face Mask, JoyMask 21-B Full Face Mask
K251920 · Dcstar, Inc. · May 2026
F6S Full Face Mask (F6S)
K253166 · BMC Medical Co., Ltd. · Apr 2026
MySleepDash
K252338 · Somnetics International, Inc. (Dba Transcend Inc) · Apr 2026
Sleepnet Arie Full Face Vented Mask
K251847 · Sleepnet Corporation · Jan 2026