Cleared Traditional

K152197 - Skypro

K152197 is an FDA 510(k) clearance for Skypro, manufactured by Skypro Medical Supplies Company. The device is a Class 2 General Hospital device with product code FXX cleared through the Traditional 510(k) pathway after a 387-day FDA review.

K152197 · Skypro Medical Supplies Company · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2016
Decision
387d
Days
Class 2
Risk

K152197 is an FDA 510(k) clearance for the Skypro, SP01 Mask. Classified as Mask, Surgical (product code FXX), Class II - Special Controls.

Submitted by Skypro Medical Supplies Company (Hong Kong, CN). The FDA issued a Cleared decision on August 26, 2016 after a review of 387 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: Standard predicate-based submission. Elevated predicate reliance profile. 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 Skypro Medical Supplies Company devices

FDA 510(k) Submission Details - K152197

510(k) Number K152197 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 05, 2015
Decision Date August 26, 2016
Days to Decision 387 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
258d slower than avg
Panel avg: 129d · This submission: 387d
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 445
Devices cleared under the same product code (FXX) and FDA review panel - the closest regulatory comparables to K152197.
3M High Performance Surgical Mask, 3M High Performance Surgical Mask with Face Shield
K180874 · 3M Healthcare · Jul 2018
Technoweb Surgical Mask
K172500 · Yts Global, Inc. · Mar 2018
Non Woven Face Mask (Models: VQN0185W (earloop) and VQN0185B (ties))
K173062 · V&Q Manufacturing Corporation · Jan 2018
Insta-Gard Surgical and Procedure Face Mask
K142990 · Cardinal Health200, LLC · Mar 2015
SECURE-GARD SURGICAL AND PROCEDURE FACE MASK
K140155 · Cardinal Health200, LLC · Jun 2014
KC 300 SURGICAL MASK
K131879 · Kimberly-Clark Corp. · Dec 2013