Cleared Traditional

K034015 - EARLOOP PROCEDURE MASK

K034015 is an FDA 510(k) clearance for EARLOOP PROCEDURE MASK, manufactured by Medipack Medical Packaging Mfg. Co.. The device is a Class 2 General Hospital device with product code FXX cleared through the Traditional 510(k) pathway after a 58-day FDA review.

K034015 · Medipack Medical Packaging Mfg. Co. · General Hospital
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Feb 2004
Decision
58d
Days
Class 2
Risk

K034015 is an FDA 510(k) clearance for the EARLOOP PROCEDURE MASK. Classified as Mask, Surgical (product code FXX), Class II - Special Controls.

Submitted by Medipack Medical Packaging Mfg. Co. (Mc Henry, US). The FDA issued a Cleared decision on February 20, 2004 after a review of 58 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.

FDA 510(k) Submission Details - K034015

510(k) Number K034015 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 24, 2003
Decision Date February 20, 2004
Days to Decision 58 days
Submission Type Traditional
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
71d faster than avg
Panel avg: 129d · This submission: 58d
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 601
Devices cleared under the same product code (FXX) and FDA review panel - the closest regulatory comparables to K034015.
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
SURGICAL FACE MASK - COLORS: WHITE, YELLOW, PINK, BLUE, AND GREEN
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MEGATECH SCIENTIFIC FACE MASK
K030239 · Megatech Scientific Pte, Ltd. · Jul 2003
SOLUTION FACE MASKS
K031353 · A Plus International, Inc. · Jun 2003
WINNER EAR LOOP PROCEDURE MASK, TIE-ON SURGICAL MASK & EAR LOOP PROCEDURE MASK WITH SHIELD
K023755 · Winner Industries (Shenzhen) Co., Ltd. · Jun 2003
K034015 · EARLOOP PROCEDURE MASK
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