Cleared Traditional

K892118 - NON-STERILE MASKS AND CAPS

K892118 is an FDA 510(k) clearance for NON-STERILE MASKS AND CAPS, manufactured by Paramount Products, Inc.. The device is a Class 2 General Hospital device with product code FYA cleared through the Traditional 510(k) pathway after a 21-day FDA review.

K892118 · Paramount Products, Inc. · General Hospital
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Apr 1989
Decision
21d
Days
Class 2
Risk

K892118 is an FDA 510(k) clearance for the NON-STERILE MASKS AND CAPS. Classified as Gown, Surgical (product code FYA), Class II - Special Controls.

Submitted by Paramount Products, Inc. (Miami, US). The FDA issued a Cleared decision on April 20, 1989 after a review of 21 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 Paramount Products, Inc. devices

FDA 510(k) Submission Details - K892118

510(k) Number K892118 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 30, 1989
Decision Date April 20, 1989
Days to Decision 21 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
108d faster than avg
Panel avg: 129d · This submission: 21d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FYA Device Classification - Class 2, Special Controls

Product Code FYA Gown, 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 - FYA Gown, Surgical

All 238
Devices cleared under the same product code (FYA) and FDA review panel - the closest regulatory comparables to K892118.
COMPEL E
K914839 · Standard Textile Co., Inc. · Apr 1992
STERILE VIEW DISP. HOOD/GOWN UV, BARRIER HOOD, UV
K901536 · Depuy, Inc. · Nov 1990
CONVERTORS BREATHABLE GOWN MATERIAL PRODUCT LINE
K896935 · Baxter Healthcare Corp · Feb 1990
KIMBERLY-CLARK IMPERVIOUS OPEN BACK GOWN
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