Cleared Traditional

AF531 Oro-Nasal EE Leak 1 Face Mask (K233555) - FDA 510(k) Clearance

Also marketed or referenced as:
AF531 Oro-Nasal EE Leak 2 Face Mask

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

K233555 · Philips Respironics · Anesthesiology device
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Jul 2024
Decision
268d
Days
Class 2
Risk

K233555 is an FDA 510(k) clearance for the AF531 Oro-Nasal EE Leak 1 Face Mask. Classified as Ventilator, Non-continuous (respirator) (product code BZD), Class II - Special Controls.

Submitted by Philips Respironics (Murrysville, US). The FDA issued a Cleared decision on July 31, 2024 after a review of 268 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 Philips Respironics devices

Submission Details

510(k) Number K233555 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 06, 2023
Decision Date July 31, 2024
Days to Decision 268 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
128d slower than avg
Panel avg: 140d · This submission: 268d
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 123
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