Cleared Traditional

K863382 - CANNON NASAL SPLINT

K863382 is the FDA 510(k) clearance for CANNON NASAL SPLINT by Treace Medical, Inc.. It is a Class 1 Ear, Nose, Throat device (product code EPP) cleared through the Traditional 510(k) pathway after a 34-day FDA review.

K863382 · Treace Medical, Inc. · Ear, Nose, Throat device
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Oct 1986
Decision
34d
Days
Class 1
Risk

K863382 is an FDA 510(k) clearance for the CANNON NASAL SPLINT. Classified as Splint, Nasal (product code EPP), Class I - General Controls.

Submitted by Treace Medical, Inc. (Memphis, US). The FDA issued a Cleared decision on October 7, 1986 after a review of 34 days - a notably fast clearance cycle.

This device falls under the Ear, Nose, Throat FDA review panel, regulated under 21 CFR 874.5800 - the FDA ear, nose and throat 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 Treace Medical, Inc. devices

Submission Details

510(k) Number K863382 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 03, 1986
Decision Date October 07, 1986
Days to Decision 34 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
55d faster than avg
Panel avg: 89d · This submission: 34d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code EPP Splint, Nasal
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 874.5800
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 - EPP Splint, Nasal

All 7
Devices cleared under the same product code (EPP) and FDA review panel - the closest regulatory comparables to K863382.
'EXMOOR' CAWOOD NASAL SPLINTS
K864932 · Exmoor Plastics , Ltd. · Mar 1987
'EXMOOR' SHAH & MACKAY NASAL SPLINTS
K864933 · Exmoor Plastics , Ltd. · Mar 1987
'EXMOOR' SHAH SILICONE DISCS
K864934 · Exmoor Plastics , Ltd. · Jan 1987
GOODE MAGNETIC NASAL SPLINT
K810738 · Xomed, Inc. · Mar 1981
THE DENVER SPLINT
K791681 · Xomed, Inc. · Oct 1979