Cleared Traditional

K810316 - SURGIKOS FACE MASK

K810316 is an FDA 510(k) clearance for SURGIKOS FACE MASK, manufactured by Surgikos, Inc.. The device is a Class 2 General Hospital device with 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

FDA 510(k) Submission Details - K810316

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
Combination Product No
PCCP Authorized No
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.

FXX Device Classification - Class 2, Special Controls

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 464
Devices cleared under the same product code (FXX) and FDA review panel - the closest regulatory comparables to K810316.
SPUNGUARD FACE MASK
K823078 · Kimberly-Clark Corp. · Jan 1983
DISPOSABLE SURGICAL FACE MASK
K820893 · Anago, Inc. · Apr 1982
CONTURA DISPOS. SURG. FACE MASK
K813078 · American Convertors Div., American Pharmaseal · Dec 1981
SURGICAL MASK
K801036 · American Threshold Industries, Inc. · Jun 1980
CONPHAR FACE MASK-STERILE
K792110 · Conphar, Inc. · Nov 1979
MASK, SURGEONS
K780607 · Abco Dealers, Inc. · Jun 1978