Cleared Abbreviated

K041047 - ULTRADENT CARBON MASK - UPI #342

K041047 is an FDA 510(k) clearance for ULTRADENT CARBON MASK - UPI #342, manufactured by Medspring Group, Incorporated. The device is a Class 2 General Hospital device with product code FXX cleared through the Abbreviated 510(k) pathway after a 223-day FDA review.

K041047 · Medspring Group, Incorporated · General Hospital
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Dec 2004
Decision
223d
Days
Class 2
Risk

K041047 is an FDA 510(k) clearance for the ULTRADENT CARBON MASK - UPI #342. Classified as Mask, Surgical (product code FXX), Class II - Special Controls.

Submitted by Medspring Group, Incorporated (Bountiful, US). The FDA issued a Cleared decision on December 1, 2004 after a review of 223 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 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.

FDA 510(k) Submission Details - K041047

510(k) Number K041047 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 22, 2004
Decision Date December 01, 2004
Days to Decision 223 days
Submission Type Abbreviated
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
94d slower than avg
Panel avg: 129d · This submission: 223d
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 601
Devices cleared under the same product code (FXX) and FDA review panel - the closest regulatory comparables to K041047.
NON-STERILE SURGICAL MASK
K051291 · A.R. Medicom, Inc. · Sep 2005
SURGICAL FACE MASK
K043199 · Hong YA Non-Woven Products Co., Ltd. · Feb 2005
PROTECTION PLUS EARLOOP PROCEDURE MASK
K042654 · Safety-Med Products, Inc. · 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
SURGICAL FACE MASK - COLORS: WHITE, YELLOW, PINK, BLUE, AND GREEN
K022256 · Tucker & Associates · Apr 2004
EARLOOP PROCEDURE MASK
K034015 · Medipack Medical Packaging Mfg. Co. · Feb 2004
K041047 · ULTRADENT CARBON MASK - UPI #342
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