Cleared Traditional

K881618 - ASEPTEX 1809 FLUID-RESISTANT MOLDED SURGICAL MASK

K881618 is an FDA 510(k) clearance for ASEPTEX 1809 FLUID-RESISTANT MOLDED SUR..., manufactured by 3M Company. The device is a Class 2 General Hospital device with product code FXX cleared through the Traditional 510(k) pathway after a 24-day FDA review.

K881618 · 3M Company · General Hospital
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May 1988
Decision
24d
Days
Class 2
Risk

K881618 is an FDA 510(k) clearance for the ASEPTEX 1809 FLUID-RESISTANT MOLDED SURGICAL MASK. Classified as Mask, Surgical (product code FXX), Class II - Special Controls.

Submitted by 3M Company (Cottae Grove, US). The FDA issued a Cleared decision on May 9, 1988 after a review of 24 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.

FDA 510(k) Submission Details - K881618

510(k) Number K881618 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 15, 1988
Decision Date May 09, 1988
Days to Decision 24 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
105d faster than avg
Panel avg: 129d · This submission: 24d
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 606
Devices cleared under the same product code (FXX) and FDA review panel - the closest regulatory comparables to K881618.
COMBO-SHIELD
K882027 · Bfd, Inc. · Jun 1988
COVERALL SHIELD
K882028 · Bfd, Inc. · Jun 1988
LABELING CHANGE TO SURGICAL FACE MASK
K881910 · Louis M. Gerson Co., Inc. · May 1988
ENDICOTT & BEAMAN SUPRA-TEC FACE MASK
K881372 · Endicott & Beaman, Inc. · Apr 1988
TECNOL LASER SURGICAL MASK
K874894 · Tecnol New Jersey Wound Care, Inc. · Mar 1988
GUARDALL SHIELD
K875008 · Anago, Inc. · Mar 1988
K881618 · ASEPTEX 1809 FLUID-RESISTANT MOLDED SURGICAL MASK
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