Cleared Traditional

K201398 - SINUSPRIME Dilation System (FDA 510(k) Clearance)

Class I Ear, Nose, Throat device.

K201398 · Stryker Ent · Ear, Nose, Throat device
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Oct 2020
Decision
140d
Days
Class 1
Risk

K201398 is an FDA 510(k) clearance for the SINUSPRIME Dilation System. Classified as Instrument, Ent Manual Surgical (product code LRC), Class I - General Controls.

Submitted by Stryker Ent (Plymouth, US). The FDA issued a Cleared decision on October 15, 2020 after a review of 140 days - within the typical 510(k) review window.

This device falls under the Ear, Nose, Throat FDA review panel, regulated under 21 CFR 874.4420 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Ear, Nose, Throat review framework, consistent with the majority of Class II 510(k) submissions.

View all Stryker Ent devices

Submission Details

510(k) Number K201398 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 28, 2020
Decision Date October 15, 2020
Days to Decision 140 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
51d slower than avg
Panel avg: 89d · This submission: 140d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LRC Instrument, Ent Manual Surgical
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 874.4420
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 - LRC Instrument, Ent Manual Surgical

All 64
Devices cleared under the same product code (LRC) and FDA review panel - the closest regulatory comparables to K201398.
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