Cleared Traditional

K853588 - FIBRELIGHT NASAL SPECULA

K853588 is an FDA 510(k) clearance for FIBRELIGHT NASAL SPECULA, manufactured by Downs Surgical , Ltd.. The device is a Class 1 General & Plastic Surgery device with product code EPY cleared through the Traditional 510(k) pathway after a 113-day FDA review.

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

FDA 510(k) Submission Details - K853588

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
2d faster than avg
Panel avg: 115d · This submission: 113d
Pathway characteristics
Predicate-based equivalence.

EPY Device Classification - Class 1, General Controls

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.

Regulatory Peers - EPY Speculum, Ent

All 10
Devices cleared under the same product code (EPY) and FDA review panel - the closest regulatory comparables to K853588.
ECONOM
K925754 · Rudolf Riester GmbH & Co. KG · Oct 1993
JAKOBI SURG. INSTRUMENTS #7 44/47
K834189 · Imm Enterprises , Ltd. · Mar 1984
UNIVERSAL SPECULUM HOLDER
K822370 · Treace Medical, Inc. · Sep 1982
EAR SURGERY SPECULUM
K822373 · Treace Medical, Inc. · Sep 1982
EAR SPECULI
K822164 · Kelleher Corp. · Aug 1982
EAR AND NOSE SPECULA
K791123 · Xomed, Inc. · Jul 1979