Cleared Traditional

K813475 - XOMED MICRO-IRRIGATOR

K813475 is the FDA 510(k) clearance for XOMED MICRO-IRRIGATOR by Xomed, Inc.. It is a Class 2 General Hospital device (product code FQH) cleared through the Traditional 510(k) pathway after a 65-day FDA review.

K813475 · Xomed, Inc. · General Hospital
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Feb 1982
Decision
65d
Days
Class 2
Risk

K813475 is an FDA 510(k) clearance for the XOMED MICRO-IRRIGATOR. Classified as Lavage, Jet (product code FQH), Class II - Special Controls.

Submitted by Xomed, Inc. (Arnold, US). The FDA issued a Cleared decision on February 4, 1982 after a review of 65 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5475 - 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 Xomed, Inc. devices

Submission Details

510(k) Number K813475 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 01, 1981
Decision Date February 04, 1982
Days to Decision 65 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
64d faster than avg
Panel avg: 129d · This submission: 65d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code FQH Lavage, Jet
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5475
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General Hospital devices follow this clearance model.