Cleared Traditional

K022256 - SURGICAL FACE MASK - COLORS: WHITE, YELLOW, PINK, BLUE, AND GREEN

K022256 is an FDA 510(k) clearance for SURGICAL FACE MASK - COLORS: WHITE, manufactured by Tucker & Associates. The device is a Class 2 General Hospital device with product code FXX cleared through the Traditional 510(k) pathway after a 654-day FDA review.

K022256 · Tucker & Associates · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Apr 2004
Decision
654d
Days
Class 2
Risk

K022256 is an FDA 510(k) clearance for the SURGICAL FACE MASK - COLORS: WHITE, YELLOW, PINK, BLUE, AND GREEN. Classified as Mask, Surgical (product code FXX), Class II - Special Controls.

Submitted by Tucker & Associates (Sparks, US). The FDA issued a Cleared decision on April 26, 2004 after a review of 654 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind General Hospital submissions.

FDA 510(k) Submission Details - K022256

510(k) Number K022256 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 12, 2002
Decision Date April 26, 2004
Days to Decision 654 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
525d slower than avg
Panel avg: 129d · This submission: 654d
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 564
Devices cleared under the same product code (FXX) and FDA review panel - the closest regulatory comparables to K022256.
PROTECTION PLUS EARLOOP PROCEDURE MASK
K042654 · Safety-Med Products, Inc. · Dec 2004
ULTRADENT CARBON MASK - UPI #342
K041047 · Medspring Group, Incorporated · Dec 2004
VALUMAX SURGICAL MASKS (BLUE, PINK, GREEN, YELLOW, WHITE AND PEACH) WITH OR WITHOUT VISORS, TIES AND EARLOOPS
K040333 · Valumax Intl., Inc. · Jun 2004
EARLOOP PROCEDURE MASK
K034015 · Medipack Medical Packaging Mfg. Co. · Feb 2004
MEGATECH SCIENTIFIC FACE MASK
K030239 · Megatech Scientific Pte, Ltd. · Jul 2003
SOLUTION FACE MASKS
K031353 · A Plus International, Inc. · Jun 2003
K022256 · SURGICAL FACE MASK - COLORS: WHITE, YELLOW, PINK, BLUE, AND GREEN
Download PDF FDA Summary Tucker & Associates