Cleared Traditional

SURGICAL MASK (K812992) - FDA 510(k) Clearance

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

K812992 · South Mountain Medical · General Hospital
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Dec 1981
Decision
38d
Days
Class 2
Risk

K812992 is an FDA 510(k) clearance for the SURGICAL MASK. Classified as Mask, Surgical (product code FXX), Class II - Special Controls.

Submitted by South Mountain Medical (Mchenry, US). The FDA issued a Cleared decision on December 3, 1981 after a review of 38 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 South Mountain Medical devices

Submission Details

510(k) Number K812992 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 26, 1981
Decision Date December 03, 1981
Days to Decision 38 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
91d faster than avg
Panel avg: 129d · This submission: 38d
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 404
Devices cleared under the same product code (FXX) and FDA review panel - the closest regulatory comparables to K812992.
ASEPTEX 1812 SUB-MICRON MOLDED SURGICAL MASK
K890771 · 3M Company · Mar 1989
ASEPTEX 1809 FLUID-RESISTANT MOLDED SURGICAL MASK
K881618 · 3M Company · May 1988
TWO-PLY PAPER FACE FACE MASK
K832281 · Abco Dealers, Inc. · Aug 1983
MASK, SURGEONS
K780607 · Abco Dealers, Inc. · Jun 1978
MASK, ISOLATION
K780609 · Abco Dealers, Inc. · May 1978