Cleared Abbreviated

K061716 - PRESTIGE AMERITECH FACE MASK

K061716 is an FDA 510(k) clearance for PRESTIGE AMERITECH FACE MASK, manufactured by Prestige Ameritech. The device is a Class 2 General Hospital device with product code FXX cleared through the Abbreviated 510(k) pathway after a 56-day FDA review.

K061716 · Prestige Ameritech · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2006
Decision
56d
Days
Class 2
Risk

K061716 is an FDA 510(k) clearance for the PRESTIGE AMERITECH FACE MASK. Classified as Mask, Surgical (product code FXX), Class II - Special Controls.

Submitted by Prestige Ameritech (Fort Worth, US). The FDA issued a Cleared decision on August 14, 2006 after a review of 56 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 Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Prestige Ameritech devices

FDA 510(k) Submission Details - K061716

510(k) Number K061716 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 19, 2006
Decision Date August 14, 2006
Days to Decision 56 days
Submission Type Abbreviated
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
73d faster than avg
Panel avg: 129d · This submission: 56d
Pathway characteristics
Standards-based clearance path.

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 445
Devices cleared under the same product code (FXX) and FDA review panel - the closest regulatory comparables to K061716.
SECURE-GARD SURGICAL AND PROCEDURE FACE MASK
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K991559 · Medline Industries, Inc. · Aug 1999
ISOSAFE EARLOOP PROCEDURE MASK (BLUE, YELLOW)
K972849 · Cypress Medical Products, Ltd. · May 1998
ISOSAFE EARLOOP PROCEDURE MASK (BLUE, YELLOW)
K972883 · Cypress Medical Products, Ltd. · Feb 1998