Cleared Traditional

sOLVe Tube

K201026 · Hytek Medical, Inc. · Anesthesiology

Aug 2021

Decision

477d

Days

Class 2

Risk

About This 510(k) Submission

K201026 is an FDA 510(k) clearance for the sOLVe Tube, a Tube, Tracheal/bronchial, Differential Ventilation (w/wo Connector) (Class II — Special Controls, product code CBI), submitted by Hytek Medical, Inc. (Northridge, US). The FDA issued a Cleared decision on August 10, 2021, 477 days after receiving the submission on April 20, 2020. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5740.

Submission Details

510(k) Number	K201026 FDA.gov
FDA Decision	Cleared SESE
Date Received	April 20, 2020
Decision Date	August 10, 2021
Days to Decision	477 days
Submission Type	Traditional
Review Panel	Anesthesiology (AN)
Summary	Summary PDF

Device Classification

Product Code	CBI — Tube, Tracheal/bronchial, Differential Ventilation (w/wo Connector)
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 868.5740