Cleared Traditional

K903759 - IRRICLEAR EAR IRRIGATION SYRINGE

K903759 is an FDA 510(k) clearance for IRRICLEAR EAR IRRIGATION SYRINGE, manufactured by Nortech Laboratories, Inc.. The device is a Class 1 General Hospital device with product code KYZ cleared through the Traditional 510(k) pathway after a 67-day FDA review.

K903759 · Nortech Laboratories, Inc. · General Hospital
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Oct 1990
Decision
67d
Days
Class 1
Risk

K903759 is an FDA 510(k) clearance for the IRRICLEAR EAR IRRIGATION SYRINGE. Classified as Syringe, Irrigating (non Dental) (product code KYZ), Class I - General Controls.

Submitted by Nortech Laboratories, Inc. (Dubuque, US). The FDA issued a Cleared decision on October 26, 1990 after a review of 67 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 Nortech Laboratories, Inc. devices

FDA 510(k) Submission Details - K903759

510(k) Number K903759 FDA.gov
FDA Decision Cleared Substantially Equivalent - Special 510(k) (SESK)
Date Received August 20, 1990
Decision Date October 26, 1990
Days to Decision 67 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
62d faster than avg
Panel avg: 129d · This submission: 67d
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 K903759.
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