Cleared Traditional

K883506 - IRRIGATION KIT (FDA 510(k) Clearance)

Class I General Hospital device.

K883506 · L H M Ent., Inc. · General Hospital
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Dec 1988
Decision
118d
Days
Class 1
Risk

K883506 is an FDA 510(k) clearance for the IRRIGATION KIT. Classified as Syringe, Irrigating (non Dental) (product code KYZ), Class I - General Controls.

Submitted by L H M Ent., Inc. (Palm Harbor, US). The FDA issued a Cleared decision on December 13, 1988 after a review of 118 days - within the typical 510(k) review window.

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 L H M Ent., Inc. devices

Submission Details

510(k) Number K883506 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 17, 1988
Decision Date December 13, 1988
Days to Decision 118 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
10d faster than avg
Panel avg: 128d · This submission: 118d
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.