Cleared Traditional

K896800 - IRRIGATION TRAY

K896800 is an FDA 510(k) clearance for IRRIGATION TRAY, manufactured by Westmark, Sterile Packing Systems, Inc. (Sps). The device is a Class 1 General Hospital device with product code KYZ cleared through the Traditional 510(k) pathway after a 174-day FDA review.

K896800 · Westmark, Sterile Packing Systems, Inc. (Sps) · General Hospital
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Optimized for regulatory review, auditing and printing
May 1990
Decision
174d
Days
Class 1
Risk

K896800 is an FDA 510(k) clearance for the IRRIGATION TRAY. Classified as Syringe, Irrigating (non Dental) (product code KYZ), Class I - General Controls.

Submitted by Westmark, Sterile Packing Systems, Inc. (Sps) (Grand Rapids, US). The FDA issued a Cleared decision on May 24, 1990 after a review of 174 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.

FDA 510(k) Submission Details - K896800

510(k) Number K896800 FDA.gov
FDA Decision Cleared Substantially Equivalent - Special 510(k) (SESK)
Date Received December 01, 1989
Decision Date May 24, 1990
Days to Decision 174 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
45d slower than avg
Panel avg: 129d · This submission: 174d
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 31
Devices cleared under the same product code (KYZ) and FDA review panel - the closest regulatory comparables to K896800.
IRRICLEAR EAR IRRIGATION SYRINGE
K903759 · Nortech Laboratories, Inc. · Oct 1990
ZEROWET SPLASHIELD
K900208 · Zerowet Splashield · Sep 1990
GRAVITY ASSIST
K902854 · Instrument Makar, Inc. · Aug 1990
STRYKER TRAUMA TRAY
K894470 · Stryker Corp. · Aug 1989
STERILE IRRIGATION TRAYS
K890728 · Cypress Medical Products, Ltd. · Jun 1989
SURGICAL SEALANT APPLICATOR
K883338 · Micromedics, Inc. · Aug 1988
K896800 · IRRIGATION TRAY
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