Cleared Traditional

ENDICOTT & BEAMAN SUPRA-TEC FACE MASK (K881372) - FDA 510(k) Clearance

Class II General Hospital device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K881372 · Endicott & Beaman, Inc. · General Hospital
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Apr 1988
Decision
7d
Days
Class 2
Risk

K881372 is an FDA 510(k) clearance for the ENDICOTT & BEAMAN SUPRA-TEC FACE MASK. Classified as Mask, Surgical (product code FXX), Class II - Special Controls.

Submitted by Endicott & Beaman, Inc. (New City, US). The FDA issued a Cleared decision on April 8, 1988 after a review of 7 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 Endicott & Beaman, Inc. devices

Submission Details

510(k) Number K881372 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 01, 1988
Decision Date April 08, 1988
Days to Decision 7 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
122d faster than avg
Panel avg: 129d · This submission: 7d
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 405
Devices cleared under the same product code (FXX) and FDA review panel - the closest regulatory comparables to K881372.
3M BRAND EAR LOOP FACE MASK, 2000F
K910182 · 3M Company · Mar 1991
ASEPTEX 1812 SUB-MICRON MOLDED SURGICAL MASK
K890771 · 3M Company · Mar 1989
ASEPTEX 1809 FLUID-RESISTANT MOLDED SURGICAL MASK
K881618 · 3M Company · May 1988
TWO-PLY PAPER FACE FACE MASK
K832281 · Abco Dealers, Inc. · Aug 1983
CONPHAR FACE MASK-STERILE
K792110 · Conphar, Inc. · Nov 1979
MASK, SURGEONS
K780607 · Abco Dealers, Inc. · Jun 1978