Cleared Traditional

K001892 - WHITE KNIGHT MASKS (21 MODELS, VARIOUS COLORS WITH AND WITHOUT FACE SHIELDS)

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
Combination Product No
PCCP Authorized No
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 529
Devices cleared under the same product code (FXX) and FDA review panel - the closest regulatory comparables to K001892.
PRIMAGARD YELLOW SURGICAL MASK, PLEATED, TIE-ON, PM4-307
K021076 · Primeline Medical Products, Inc. · Apr 2002
CROSSTEX ISOLITE EARLOOP FACE MASKS-BLUE, PINK, CROSSTEX ISOFLUID EARLOOP FACE MASKS-BLUE, PINK, WHITE, GREEN. CROSSTEX
K012602 · Crosstex Intl. · Jan 2002
PROCEDURE MASKS: PM4-301 AND PM4-304
K011789 · Primeline Medical Products, Inc. · Jun 2001
WHITE KNIGHT MASKS, BLUE, PINK, YELLOW, WHITE MASKS (13 MODELS)
K001893 · White Knight Healthcare, Inc. · Apr 2001
WHITE KNIGHT BLUE, GREEN FACE MASK, (4 MODELS)
K001997 · White Knight Healthcare, Inc. · Apr 2001
PRIMED PLEATED TIE-BACK, PROCEDURE MASK PM4-305, PRIMED PLEATED EAR-LOOP, PROCEDURE MASK PM4-306
K001951 · Primeline Medical Products, Inc. · Sep 2000