AF531 Oro-Nasal EE Leak 1 Face Mask; AF531 Oro-Nasal EE Leak 2 Face Mask— 510(k) K233555

Name: FDA 510(k) clearance K233555
Creator: U.S. Food and Drug Administration
Published: 2024-07-31

Substantially Equivalent

Philips Respironics

FDA 510(k) clearance K233555 for AF531 Oro-Nasal EE Leak 1 Face Mask; AF531 Oro-Nasal EE Leak 2 Face Mask, Substantially Equivalent on 2024-07-31. Applicant: Philips Respironics. Device class: 2.

Clearance details

Applicant: Philips Respironics
Product code: Code BZD
Device class: Class 2
Regulation: 21 CFR 868.5905
Advisory panel: Anesthesiology
Date received: 2023-11-06
Decision date: 2024-07-31
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Murrysville, PA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code BZD

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K253553 — Orion2026-06-04
K254104 — ResScan Essentials2026-05-27
K251920 — Sleep Apnea Breathing Therapy Mask:JoyMask 20-B Full Face Mask, JoyMask 21-B Full Face Mask2026-05-21
K253166 — F6S Full Face Mask (F6S); P6S Nasal Pillows Interface (P6S)2026-04-29

Adverse events under product code BZD

product code BZD

Death: 4,440
Injury: 53,099
Malfunction: 213,222
Other: 17
Total: 270,778

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.