Cleared Abbreviated

Surgical Face Mask, Surgical Mask (K201844) - FDA 510(k) Clearance

Class II General Hospital device cleared through the Abbreviated 510(k) pathway - typically does not require clinical trials.

K201844 · Lear Corporation · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2021
Decision
373d
Days
Class 2
Risk

K201844 is an FDA 510(k) clearance for the Surgical Face Mask, Surgical Mask. Classified as Mask, Surgical (product code FXX), Class II - Special Controls.

Submitted by Lear Corporation (Pine Grove, US). The FDA issued a Cleared decision on July 14, 2021 after a review of 373 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 878.4040 - the FDA general hospital device framework. The Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Lear Corporation devices

Submission Details

510(k) Number K201844 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 06, 2020
Decision Date July 14, 2021
Days to Decision 373 days
Submission Type Abbreviated
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
244d slower than avg
Panel avg: 129d · This submission: 373d
Pathway characteristics
Standards-based clearance path.

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 405
Devices cleared under the same product code (FXX) and FDA review panel - the closest regulatory comparables to K201844.
Single-Use Surgical Mask Model FE2311B
K210970 · Byd Precison Manufacturer Co., Ltd. · Jul 2021
Velguard Surgical Face Mask
K210761 · Esstee Exports Health Care Division · Jul 2021
Disposable Procedural Ear-loop Face Mask
K211042 · Changzhou Dsb Medical Co., Ltd. · Jul 2021
Disposable Medical Face Mask
K210244 · Suzhou Bolisi Medical Technology Co., Ltd. · Jul 2021
Disposable Surgical Mask
K210267 · Xiamen Eagledon Pharmaceutical Co., Ltd. · Jul 2021
Medical surgical mask
K210380 · Shantou T&K Medical Equipment Factory Co.,Ltd · Jul 2021