Cleared Traditional

K231618 - 3 Layer Surgical Mask (134252531) (FDA 510(k) Clearance)

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

K231618 · Original Mattress Factory, Inc. · General Hospital
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Optimized for regulatory review, auditing and printing
Jul 2023
Decision
56d
Days
Class 2
Risk

K231618 is an FDA 510(k) clearance for the 3 Layer Surgical Mask (134252531). Classified as Mask, Surgical (product code FXX), Class II - Special Controls.

Submitted by Original Mattress Factory, Inc. (Cleveland, US). The FDA issued a Cleared decision on July 28, 2023 after a review of 56 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 878.4040 - the FDA general hospital 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Original Mattress Factory, Inc. devices

Submission Details

510(k) Number K231618 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 02, 2023
Decision Date July 28, 2023
Days to Decision 56 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
72d faster than avg
Panel avg: 128d · This submission: 56d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code FXX Mask, Surgical
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4040
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 General Hospital devices follow this clearance model.

Regulatory Peers - FXX Mask, Surgical

All 606
Devices cleared under the same product code (FXX) and FDA review panel - the closest regulatory comparables to K231618.
HALYARD* FLUIDSHIELD* 3 Fog-Free Procedure Mask with SO SOFT* Lining and SO SOFT* Earloops
K251967 · O&M Halyard, Inc. · Mar 2026
Surgical Face Mask (Ear mount)
K252534 · Zhejiang Hangkang Medical Equipment Co., Ltd. · Mar 2026
Disposable Surgical Mask (Non-Sterile) (EFX3PLBLKMSK300)
K253398 · Efofex, Inc. · Feb 2026
Disposable Surgical Face Mask (3P00B, C2900)
K252830 · Beatles Medical Supplies (Xiantao) Co., Ltd. · Jan 2026
Disposable Medical Face Mask
K252650 · Makrite Industries, Inc. · Jan 2026
KP Protective Face Mask
K243342 · Kp Trading Co., Ltd. · Dec 2025