Cleared Traditional

K890771 - ASEPTEX 1812 SUB-MICRON MOLDED SURGICAL MASK

K890771 is an FDA 510(k) clearance for ASEPTEX 1812 SUB-MICRON MOLDED SURGICAL..., 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 28-day FDA review.

K890771 · 3M Company · General Hospital
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Mar 1989
Decision
28d
Days
Class 2
Risk

K890771 is an FDA 510(k) clearance for the ASEPTEX 1812 SUB-MICRON 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 March 14, 1989 after a review of 28 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 - K890771

510(k) Number K890771 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 14, 1989
Decision Date March 14, 1989
Days to Decision 28 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
101d faster than avg
Panel avg: 129d · This submission: 28d
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 K890771.
SPLASH GUARD GOGGLE
K891052 · Dispomed, Inc. · Apr 1989
SURGICAL CONE MASK
K891056 · Dispomed, Inc. · Apr 1989
PRECEPT MICRO-GARD LASER MASK
K891409 · Mars White Knight · Apr 1989
FACELOCK FILTER MASK
K890128 · Alpha Protech, Inc. · Feb 1989
FACE MASK
K890016 · Anjudd Intl. · Feb 1989
OCUSHIELDS MASKS
K884877 · Dioptics · Jan 1989
K890771 · ASEPTEX 1812 SUB-MICRON MOLDED SURGICAL MASK
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