Cleared Traditional

K894470 - STRYKER TRAUMA TRAY

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

K894470 · Stryker Corp. · General Hospital

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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

Submission Details

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.

Device Classification

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 7

Devices cleared under the same product code (KYZ) and FDA review panel - the closest regulatory comparables to K894470.

RMI DUAL FLUID IRRIGATING SYRINGE

K964833 · Research Medical, Inc. · Feb 1997

WELCH ALLYN EARCLEANER

K931946 · Welch Allyn, Inc. · Jul 1993

IRRIGATION TRAY W/ BULB SYRINGE

K924809 · Customed, Inc. · Jun 1993

CLEAN-FLUSH

K830572 · Burron Medical Products, Inc. · Mar 1983

IRRIJET

K810209 · Ackrad Laboratories · Feb 1981

IRRIGATION CAP

K780794 · Travenol Laboratories, S.A. · Jul 1978

Related FDA 510(k) Regulatory Insights

Additional regulatory intelligence related to this FDA 510(k) submission, including predicate strategy, review pathways and device classification guidance.

Manufacturer of K894470

Stryker Corp.

Rockville, MD · US

SALMAN, PH.D.

Regulatory profile

124 submissions 121 cleared

98% clearance rate · Active in General Hospital

Data Intelligence Layer

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Classification enrichment, manufacturer tracking and cross-device links are added to support regulatory research and predicate analysis workflows.

Sourced from FDA 510(k) public files . Updated monthly.

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