Cleared Traditional

K111559 - SURGICAL MASKS

K111559 is an FDA 510(k) clearance for SURGICAL MASKS, manufactured by Shanghai Neo-Medical Import & Export Co., Ltd.. The device is a Class 2 General Hospital device with product code FXX cleared through the Traditional 510(k) pathway after a 102-day FDA review.

K111559 · Shanghai Neo-Medical Import & Export Co., Ltd. · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Sep 2011
Decision
102d
Days
Class 2
Risk

K111559 is an FDA 510(k) clearance for the SURGICAL MASKS. Classified as Mask, Surgical (product code FXX), Class II - Special Controls.

Submitted by Shanghai Neo-Medical Import & Export Co., Ltd. (Shanghai, CN). The FDA issued a Cleared decision on September 16, 2011 after a review of 102 days - within the typical 510(k) review window.

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.

FDA 510(k) Submission Details - K111559

510(k) Number K111559 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 06, 2011
Decision Date September 16, 2011
Days to Decision 102 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
27d faster than avg
Panel avg: 129d · This submission: 102d
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 K111559.
FACE MASK, SURGICAL MASK, PROCEDURE MASK, SURGICAL FACE MASK
K122717 · Tiger Medical Products, Ltd. · Dec 2012
KC200, SURGICAL MASK, KC200, PROCEDURE MASK, KC300, SURGICALMASK, FLUIDSHIELD, KC300, PROCEDURE MASK, FLUIDSHIELD MODEL
K111402 · Kimberly-Clark · Oct 2011
CROSSTEX ISOFLUID PLUS SURGICAL EARLOOP MASK-BLUE, CROSSTEX ISOFLUID PLUS FOGFREE SURGICAL EARLOOP FACE MASK-BLUE, CROSS
K111343 · Crosstex International, Inc. · Oct 2011
SURGICAL FACE MASK
K110027 · Angeline Group , Ltd. · Aug 2011
KIMBERLY-CLARK LOW BARRIER, ASTM 2100 FACE MASKS
K110455 · Kimberly-Clark Corp. · Apr 2011
TIGER FLAT SURGICAL MASK
K102713 · Tiger Medical Products, Ltd. · Jan 2011
K111559 · SURGICAL MASKS
Download PDF FDA Summary Shanghai Neo-Medical …