Cleared Traditional

Skypro, SP01 Mask (K152197) - FDA 510(k) Clearance

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

K152197 · Skypro Medical Supplies Company · General Hospital
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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

Submission Details

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.

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 405
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
MEDLINE PROHIBIT SERIES SURGICAL MASK WITH FLUID SHIELD
K991559 · Medline Industries, Inc. · Aug 1999
DEPUY OPTI-CON AND E-Z SHIELD SYSTEMS
K964114 · Depuy, Inc. · May 1997
MEDLINE ADMISSION KITS
K965107 · Medline Industries, Inc. · Mar 1997