Cleared Traditional

K001892 - WHITE KNIGHT MASKS (21 MODELS

K001892 is an FDA 510(k) clearance for WHITE KNIGHT MASKS (21 MODELS, manufactured by White Knight Healthcare, Inc.. The device is a Class 2 General Hospital device with product code FXX cleared through the Traditional 510(k) pathway after a 286-day FDA review.

K001892 · White Knight Healthcare, Inc. · General Hospital
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Apr 2001
Decision
286d
Days
Class 2
Risk

K001892 is an FDA 510(k) clearance for the WHITE KNIGHT MASKS (21 MODELS, VARIOUS COLORS WITH AND WITHOUT FACE SHIELDS). Classified as Mask, Surgical (product code FXX), Class II - Special Controls.

Submitted by White Knight Healthcare, Inc. (New Port Riche, US). The FDA issued a Cleared decision on April 3, 2001 after a review of 286 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all White Knight Healthcare, Inc. devices

FDA 510(k) Submission Details - K001892

510(k) Number K001892 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 21, 2000
Decision Date April 03, 2001
Days to Decision 286 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
157d slower than avg
Panel avg: 129d · This submission: 286d
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 446
Devices cleared under the same product code (FXX) and FDA review panel - the closest regulatory comparables to K001892.
SECURE-GARD SURGICAL AND PROCEDURE FACE MASK
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KC 300 SURGICAL MASK
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KIMBERLY-CLARK LOW BARRIER, ASTM 2100 FACE MASKS
K110455 · Kimberly-Clark Corp. · Apr 2011
MEDLINE PROHIBIT SERIES SURGICAL MASK WITH FLUID SHIELD
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