sOLVe Tube— 510(k) K201026

Name: FDA 510(k) clearance K201026
Creator: U.S. Food and Drug Administration
Published: 2021-08-10

Substantially Equivalent

Hytek Medical, Inc.

FDA 510(k) clearance K201026 for sOLVe Tube, Substantially Equivalent on 2021-08-10. Applicant: Hytek Medical, Inc.. Device class: 2.

Clearance details

Applicant: Hytek Medical, Inc.
Product code: Code CBI
Device class: Class 2
Regulation: 21 CFR 868.5740
Advisory panel: Anesthesiology
Date received: 2020-04-20
Decision date: 2021-08-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Northridge, CA, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code CBI

product code CBI

Death: 4
Malfunction: 594
Total: 598

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.