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Solve Tube

by Hytek Medical, Inc.

510(k) K201026

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK201026 Date10 Aug 2021ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
CBI
Device Class
Class II
Regulation
21 CFR Part 868.5740
Advisory Committee
Anesthesiology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 26 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Solve Tube is a dual-lumen endobronchial tube kit designed for lung isolation and ventilation. It is used to isolate the left or right lung of a patient for surgery, one-lung ventilation, or one-lung anesthesia.

This device is intended for single-use by healthcare professionals in hospital settings. It is a Class II medical device regulated under 21 CFR 868.5740 and has received FDA 510(k) clearance.

Questions

AI-generated answers, 26 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the primary clinical use of the sOLVe Tube?

    The sOLVe Tube is a dual-lumen endobronchial tube designed to facilitate lung isolation and ventilation. It is specifically intended for use by healthcare professionals during surgical procedures requiring one-lung ventilation or one-lung anesthesia.

  • Is the sOLVe Tube intended for multiple uses?

    No, the sOLVe Tube is intended for single-use only. It is designed to be used once by healthcare professionals in a hospital setting to ensure patient safety and prevent cross-contamination.

  • What is the regulatory status of this device?

    The sOLVe Tube is a Class II medical device regulated under 21 CFR 868.5740. It has received FDA 510(k) clearance under the K-number K201026, confirming it is substantially equivalent to existing devices in the anesthesiology specialty.