Cleared Traditional

AF531 Oro-Nasal SE Face Mask

K243394 · Respironics, Inc. · Anesthesiology
Dec 2024
Decision
60d
Days
Class 2
Risk

About This 510(k) Submission

K243394 is an FDA 510(k) clearance for the AF531 Oro-Nasal SE Face Mask, a Ventilator, Continuous, Facility Use (Class II — Special Controls, product code CBK), submitted by Respironics, Inc. (Murrysville, US). The FDA issued a Cleared decision on December 30, 2024, 60 days after receiving the submission on October 31, 2024. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5895.

Submission Details

510(k) Number K243394 FDA.gov
FDA Decision Cleared SESE
Date Received October 31, 2024
Decision Date December 30, 2024
Days to Decision 60 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF

Device Classification

Product Code CBK — Ventilator, Continuous, Facility Use
Device Class Class II — Special Controls
CFR Regulation 21 CFR 868.5895

Similar Devices — CBK Ventilator, Continuous, Facility Use

All 502
VPAP Pediatric Face Mask
K251888 · Hsiner Co., Ltd. · Mar 2026
Vivo 45 LS
K232365 · Oconnell Regulatory Consultants, Inc. · Dec 2025
F&P OptiNIV Hospital Vented Full Face Mask Compatible with Single-limb Circuits ? Size A (ONIV117A); F&P OptiNIV Hospital Vented Full Face Mask Compatible with Single-limb Circuits ? Size B (ONIV117B); F&P OptiNIV Hospital Vented Full Face Mask Compatible with Single-limb Circuits ? Size C (ONIV117C); F&P OptiNIV ONIV117-F Hospital Vented Full Face Mask with optional Expiratory Filter Compatible with Single-limb Circuits - Size A (ONIV117A-F); F&P OptiNIV ONIV117-F Hospital Vented Full
K252173 · Fisher &Paykel Healthcare , Ltd. · Sep 2025
SV600, SV800 Ventilator
K243767 · Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · Aug 2025
AVEA disposable expiratory filter/water trap (11790)
K251133 · Telesair, Inc. · May 2025
731 Series Ventilator
K233486 · ZOLL Medical Corporation · Dec 2024