Cleared Traditional

K922716 - SPLASH SHIELD # 4505, 4507, PARASHIELD # 4509

K922716 is an FDA 510(k) clearance for SPLASH SHIELD # 4505, manufactured by Splash Shield, Inc.. The device is a Class 2 General Hospital device with product code FXX cleared through the Traditional 510(k) pathway after a 140-day FDA review.

K922716 · Splash Shield, Inc. · General Hospital
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Oct 1992
Decision
140d
Days
Class 2
Risk

K922716 is an FDA 510(k) clearance for the SPLASH SHIELD # 4505, 4507, PARASHIELD # 4509. Classified as Mask, Surgical (product code FXX), Class II - Special Controls.

Submitted by Splash Shield, Inc. (Woburn, US). The FDA issued a Cleared decision on October 23, 1992 after a review of 140 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.

View all Splash Shield, Inc. devices

FDA 510(k) Submission Details - K922716

510(k) Number K922716 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 05, 1992
Decision Date October 23, 1992
Days to Decision 140 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
11d slower than avg
Panel avg: 129d · This submission: 140d
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 520
Devices cleared under the same product code (FXX) and FDA review panel - the closest regulatory comparables to K922716.
BUFFALO FILTER SURGICAL MASK
K930067 · Buffalo Filter Co., Inc. · Nov 1993
TECNOL FLUIDSHIELD INFECTION CONTROL MASK
K915817 · Tecnol Medical Products, Inc. · Jan 1993
TECNOL FLUIDSHIELD W/SPLASHGUARD VIS INFEC CONT MK
K920162 · Tecnol Medical Products, Inc. · Jan 1993
TECNOL INFECTION CONTROL MASK
K920203 · Tecnol Medical Products, Inc. · Oct 1992
CENTRAL VENOUS CATHETER, DRESSING CHANGE KIT, STER
K920846 · Trinity Laboratories, Inc. · Sep 1992
SURGICAL APPAREL
K914832 · W.L. Gore & Associates, Inc. · Feb 1992