Cleared Traditional

K900208 - ZEROWET SPLASHIELD

K900208 is an FDA 510(k) clearance for ZEROWET SPLASHIELD, manufactured by Zerowet Splashield. The device is a Class 1 General Hospital device with product code KYZ cleared through the Traditional 510(k) pathway after a 230-day FDA review.

K900208 · Zerowet Splashield · General Hospital
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Sep 1990
Decision
230d
Days
Class 1
Risk

K900208 is an FDA 510(k) clearance for the ZEROWET SPLASHIELD. Classified as Syringe, Irrigating (non Dental) (product code KYZ), Class I - General Controls.

Submitted by Zerowet Splashield (Redondo Beach, US). The FDA issued a Cleared decision on September 4, 1990 after a review of 230 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 Zerowet Splashield devices

FDA 510(k) Submission Details - K900208

510(k) Number K900208 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 17, 1990
Decision Date September 04, 1990
Days to Decision 230 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
101d slower than avg
Panel avg: 129d · This submission: 230d
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 26
Devices cleared under the same product code (KYZ) and FDA review panel - the closest regulatory comparables to K900208.
IRRIGATION TRAY W/ BULB SYRINGE
K924809 · Customed, Inc. · Jun 1993
SPLASH GUARD
K905173 · E.M. Adams · Apr 1991
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
STRYKER TRAUMA TRAY
K894470 · Stryker Corp. · Aug 1989