Cleared Abbreviated

Heartland Health Surgical Mask (K212366) - FDA 510(k) Clearance

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

K212366 · Heartland Health Products · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2022
Decision
204d
Days
Class 2
Risk

K212366 is an FDA 510(k) clearance for the Heartland Health Surgical Mask. Classified as Mask, Surgical (product code FXX), Class II - Special Controls.

Submitted by Heartland Health Products (Cincinnati, US). The FDA issued a Cleared decision on February 19, 2022 after a review of 204 days - an extended review cycle.

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 Heartland Health Products devices

Submission Details

510(k) Number K212366 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 30, 2021
Decision Date February 19, 2022
Days to Decision 204 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
75d slower than avg
Panel avg: 129d · This submission: 204d
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 K212366.
ASTM Level 1/EN14683 Type IIR 3-Ply disposable Surgical Mask, Model number: FM-1400G
K203376 · Medtecs (Taiwan) Corp. · Mar 2022
ROKI Surgical Mask
K214094 · Roki Co., Ltd. · Feb 2022
Medical Surgical Mask
K213724 · Hunan Zhenheyikang Medical Instrument Co., Ltd. · Feb 2022
Surgical Face Mask
K212863 · Taiwan Comfort Champ Manufacturing Co., Ltd. · Feb 2022
Surgical Face Mask
K213617 · Megasoft (China) Co., Ltd. · Feb 2022
Surgical Masks
K212120 · Hubei Xinxin Non-Woven Co., Ltd. · Jan 2022