Cleared Traditional

K253166 - F6S Full Face Mask (F6S) (FDA 510(k) Clearance)

Also includes:
P6S Nasal Pillows Interface (P6S)

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

K253166 · BMC Medical Co., Ltd. · Anesthesiology device
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Apr 2026
Decision
215d
Days
Class 2
Risk

K253166 is an FDA 510(k) clearance for the F6S Full Face Mask (F6S). Classified as Ventilator, Non-continuous (respirator) (product code BZD), Class II - Special Controls.

Submitted by BMC Medical Co., Ltd. (Beijing, CN). The FDA issued a Cleared decision on April 29, 2026 after a review of 215 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 BMC Medical Co., Ltd. devices

Submission Details

510(k) Number K253166 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 26, 2025
Decision Date April 29, 2026
Days to Decision 215 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
76d slower than avg
Panel avg: 139d · This submission: 215d
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 456
Devices cleared under the same product code (BZD) and FDA review panel - the closest regulatory comparables to K253166.
MySleepDash
K252338 · Somnetics International, Inc. (Dba Transcend Inc) · Apr 2026
Sleepnet Arie Full Face Vented Mask
K251847 · Sleepnet Corporation · Jan 2026
DeltaWave Nasal Pillow System
K253939 · RemSleep Holdings, Inc. · Jan 2026
SleepRes PAP System
K251770 · Sleepres, Inc. · Dec 2025
Personalized Therapy Comfort Settings (PTCS)
K251657 · ResMed Corp · Dec 2025
F&P Nova Nasal Mask
K243583 · Fisher & Paykel Healthcare Limited · Jun 2025