Cleared Traditional

FLORET NASAL TAMPON (K830263) - FDA 510(k) Clearance

Class I General & Plastic Surgery device.

K830263 · Ritmed, Inc. · General & Plastic Surgery device
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Mar 1983
Decision
58d
Days
Class 1
Risk

K830263 is an FDA 510(k) clearance for the FLORET NASAL TAMPON. Classified as Splint, Intranasal Septal (product code LYA), Class I - General Controls.

Submitted by Ritmed, Inc. (Mchenry, US). The FDA issued a Cleared decision on March 24, 1983 after a review of 58 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 874.4780 - the FDA general and plastic surgery 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 Ritmed, Inc. devices

Submission Details

510(k) Number K830263 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 25, 1983
Decision Date March 24, 1983
Days to Decision 58 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
57d faster than avg
Panel avg: 115d · This submission: 58d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LYA Splint, Intranasal Septal
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 874.4780
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 - LYA Splint, Intranasal Septal

All 45
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