Cleared Traditional

K810316 - SURGIKOS FACE MASK

K810316 is the FDA 510(k) clearance for SURGIKOS FACE MASK by Surgikos, Inc.. It is a Class 2 General Hospital device (product code FXX) cleared through the Traditional 510(k) pathway after a 17-day FDA review.

K810316 · Surgikos, Inc. · General Hospital
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Feb 1981
Decision
17d
Days
Class 2
Risk

K810316 is an FDA 510(k) clearance for the SURGIKOS FACE MASK. Classified as Mask, Surgical (product code FXX), Class II - Special Controls.

Submitted by Surgikos, Inc. (Mchenry, US). The FDA issued a Cleared decision on February 23, 1981 after a review of 17 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 Surgikos, Inc. devices

Submission Details

510(k) Number K810316 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 06, 1981
Decision Date February 23, 1981
Days to Decision 17 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
112d faster than avg
Panel avg: 129d · This submission: 17d
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 410
Devices cleared under the same product code (FXX) and FDA review panel - the closest regulatory comparables to K810316.
KLEENSPEC DISPOSABLE FACE SHIELD, MODEL 57001
K875194 · Welch Allyn, Inc. · Jan 1988
TWO-PLY PAPER FACE FACE MASK
K832281 · Abco Dealers, Inc. · Aug 1983
SPUNGUARD FACE MASK
K823078 · Kimberly-Clark Corp. · Jan 1983
CONPHAR FACE MASK-STERILE
K792110 · Conphar, Inc. · Nov 1979
MASK, SURGEONS
K780607 · Abco Dealers, Inc. · Jun 1978
MASK, ISOLATION
K780609 · Abco Dealers, Inc. · May 1978