Cleared Traditional

K853588 - FIBRELIGHT NASAL SPECULA (FDA 510(k) Clearance)

Class I General & Plastic Surgery device.

K853588 · Downs Surgical , Ltd. · General & Plastic Surgery device
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Dec 1985
Decision
113d
Days
Class 1
Risk

K853588 is an FDA 510(k) clearance for the FIBRELIGHT NASAL SPECULA. Classified as Speculum, Ent (product code EPY), Class I - General Controls.

Submitted by Downs Surgical , Ltd. (Wilmington, US). The FDA issued a Cleared decision on December 18, 1985 after a review of 113 days - within the typical 510(k) review window.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.1800 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

View all Downs Surgical , Ltd. devices

Submission Details

510(k) Number K853588 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 27, 1985
Decision Date December 18, 1985
Days to Decision 113 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
1d faster than avg
Panel avg: 114d · This submission: 113d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code EPY Speculum, Ent
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 878.1800
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.