Cleared Traditional

K881618 - ASEPTEX 1809 FLUID-RESISTANT MOLDED SUR...

K881618 is the FDA 510(k) clearance for ASEPTEX 1809 FLUID-RESISTANT MOLDED SUR... by 3M Company. It is a Class 2 General Hospital device (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.

View all 3M Company devices

Submission Details

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.

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 433
Devices cleared under the same product code (FXX) and FDA review panel - the closest regulatory comparables to K881618.
THE PROTECTOR II, LASER SURGICAL MASK
K902547 · Anago, Inc. · Sep 1990
TECNOL LAZER(TM) SURGICAL MASK
K896193 · Tecnol New Jersey Wound Care, Inc. · Feb 1990
ASEPTEX 1812 SUB-MICRON MOLDED SURGICAL MASK
K890771 · 3M Company · Mar 1989
TECNOL LASER SURGICAL MASK
K874894 · Tecnol New Jersey Wound Care, Inc. · Mar 1988
GUARDALL SHIELD
K875008 · Anago, Inc. · Mar 1988
TECNOL FLUID SHIELD SURGICAL MASK W/EYEGUARD
K880757 · Tecnol New Jersey Wound Care, Inc. · Mar 1988