Cleared Traditional

K233555 - AF531 Oro-Nasal EE Leak 1 Face Mask

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

K233555 is an FDA 510(k) clearance for AF531 Oro-Nasal EE Leak 1 Face Mask, manufactured by Philips Respironics. The device is a Class 2 Anesthesiology device with product code BZD cleared through the Traditional 510(k) pathway after a 268-day FDA review.

K233555 · Philips Respironics · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K233555

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.

BZD Device Classification - Class 2, Special Controls

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 285
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