Cleared Traditional

Technoweb Surgical Mask (K172500) - FDA 510(k) Clearance

Class II General Hospital device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K172500 · Yts Global, Inc. · General Hospital
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Mar 2018
Decision
195d
Days
Class 2
Risk

K172500 is an FDA 510(k) clearance for the Technoweb Surgical Mask. Classified as Mask, Surgical (product code FXX), Class II - Special Controls.

Submitted by Yts Global, Inc. (Springfield, US). The FDA issued a Cleared decision on March 1, 2018 after a review of 195 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 Yts Global, Inc. devices

Submission Details

510(k) Number K172500 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 18, 2017
Decision Date March 01, 2018
Days to Decision 195 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
66d slower than avg
Panel avg: 129d · This submission: 195d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 408
Devices cleared under the same product code (FXX) and FDA review panel - the closest regulatory comparables to K172500.
Surgical Face Mask
K182515 · Wuhan Dymex Healthcare Co., Ltd. · May 2019
Surgical Face Mask
K182514 · Xiantao Zhibo Non-Woven Products Co., Ltd. · Jan 2019
3M High Performance Surgical Mask, 3M High Performance Surgical Mask with Face Shield
K180874 · 3M Healthcare · Jul 2018
Non Woven Face Mask (Models: VQN0185W (earloop) and VQN0185B (ties))
K173062 · V&Q Manufacturing Corporation · Jan 2018
KC 300 SURGICAL MASK
K131879 · Kimberly-Clark Corp. · Dec 2013
KIMBERLY-CLARK LOW BARRIER, ASTM 2100 FACE MASKS
K110455 · Kimberly-Clark Corp. · Apr 2011