Cleared Traditional

K822481 - MULTIPLE SURGICAL MASK

K822481 is an FDA 510(k) clearance for MULTIPLE SURGICAL MASK, manufactured by Surgilite Intl., Inc.. The device is a Class 2 General Hospital device with product code FXX cleared through the Traditional 510(k) pathway after a 31-day FDA review.

K822481 · Surgilite Intl., Inc. · General Hospital
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Sep 1982
Decision
31d
Days
Class 2
Risk

K822481 is an FDA 510(k) clearance for the MULTIPLE SURGICAL MASK. Classified as Mask, Surgical (product code FXX), Class II - Special Controls.

Submitted by Surgilite Intl., Inc. (Mchenry, US). The FDA issued a Cleared decision on September 17, 1982 after a review of 31 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 Surgilite Intl., Inc. devices

FDA 510(k) Submission Details - K822481

510(k) Number K822481 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 17, 1982
Decision Date September 17, 1982
Days to Decision 31 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
98d faster than avg
Panel avg: 129d · This submission: 31d
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 522
Devices cleared under the same product code (FXX) and FDA review panel - the closest regulatory comparables to K822481.
SURGICAL FACE MASK-DISPOSABLE
K832194 · Tecnol New Jersey Wound Care, Inc. · Jul 1983
SURGICAL FACE MASK
K830890 · Busse Hospital Disposables, Inc. · Apr 1983
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
SURGIKOS FACE MASK
K810316 · Surgikos, Inc. · Feb 1981