Cleared Traditional

K924809 - IRRIGATION TRAY W/ BULB SYRINGE (FDA 510(k) Clearance)

Class I General Hospital device.

K924809 · Customed, Inc. · General Hospital
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Jun 1993
Decision
256d
Days
Class 1
Risk

K924809 is an FDA 510(k) clearance for the IRRIGATION TRAY W/ BULB SYRINGE. Classified as Syringe, Irrigating (non Dental) (product code KYZ), Class I - General Controls.

Submitted by Customed, Inc. (Fajardo, US). The FDA issued a Cleared decision on June 7, 1993 after a review of 256 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 Customed, Inc. devices

Submission Details

510(k) Number K924809 FDA.gov
FDA Decision Cleared Substantially Equivalent - De Novo Granted (SEKD)
Date Received September 24, 1992
Decision Date June 07, 1993
Days to Decision 256 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
128d slower than avg
Panel avg: 128d · This submission: 256d
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.