Cleared Traditional

K905173 - SPLASH GUARD

K905173 is an FDA 510(k) clearance for SPLASH GUARD, manufactured by E.M. Adams. The device is a Class 1 General Hospital device with product code KYZ cleared through the Traditional 510(k) pathway after a 160-day FDA review.

K905173 · E.M. Adams · General Hospital
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Apr 1991
Decision
160d
Days
Class 1
Risk

K905173 is an FDA 510(k) clearance for the SPLASH GUARD. Classified as Syringe, Irrigating (non Dental) (product code KYZ), Class I - General Controls.

Submitted by E.M. Adams (Medfield, US). The FDA issued a Cleared decision on April 25, 1991 after a review of 160 days - an extended review cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.6960 - 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 E.M. Adams devices

FDA 510(k) Submission Details - K905173

510(k) Number K905173 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 16, 1990
Decision Date April 25, 1991
Days to Decision 160 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
31d slower than avg
Panel avg: 129d · This submission: 160d
Pathway characteristics
Predicate-based equivalence.

KYZ Device Classification - Class 1, General Controls

Product Code KYZ Syringe, Irrigating (non Dental)
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 880.6960
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - KYZ Syringe, Irrigating (non Dental)

All 17
Devices cleared under the same product code (KYZ) and FDA review panel - the closest regulatory comparables to K905173.
SURGICAL SEALANT APPLICATOR TIP ENDOSCOPIC TIP
K940371 · Micromedics, Inc. · Apr 1994
WELCH ALLYN EARCLEANER
K931946 · Welch Allyn, Inc. · Jul 1993
IRRIGATION TRAY W/ BULB SYRINGE
K924809 · Customed, Inc. · Jun 1993
INSTRUMENT MAKAR GRAVITY ASSIST SYSTEM
K905365 · Instrument Makar, Inc. · Feb 1991
GRAVITY ASSIST
K902854 · Instrument Makar, Inc. · Aug 1990
IRRIGATION TRAY
K896800 · Westmark, Sterile Packing Systems, Inc. (Sps) · May 1990