Cleared Traditional

K894470 - STRYKER TRAUMA TRAY

K894470 is an FDA 510(k) clearance for STRYKER TRAUMA TRAY, manufactured by Stryker Corp.. The device is a Class 1 General Hospital device with product code KYZ cleared through the Traditional 510(k) pathway after a 31-day FDA review.

K894470 · Stryker Corp. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1989
Decision
31d
Days
Class 1
Risk

K894470 is an FDA 510(k) clearance for the STRYKER TRAUMA TRAY. Classified as Syringe, Irrigating (non Dental) (product code KYZ), Class I - General Controls.

Submitted by Stryker Corp. (Rockville, US). The FDA issued a Cleared decision on August 18, 1989 after a review of 31 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Stryker Corp. devices

FDA 510(k) Submission Details - K894470

510(k) Number K894470 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 18, 1989
Decision Date August 18, 1989
Days to Decision 31 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
98d faster than avg
Panel avg: 129d · This submission: 31d
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 24
Devices cleared under the same product code (KYZ) and FDA review panel - the closest regulatory comparables to K894470.
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
STERILE IRRIGATION TRAYS
K890728 · Cypress Medical Products, Ltd. · Jun 1989
SURGICAL SEALANT APPLICATOR
K883338 · Micromedics, Inc. · Aug 1988
SURGICAL SEALANT DISPENSER (SSD)
K881020 · Micromedics, Inc. · Mar 1988