OR TUBE RESTRAINT— 510(k) K851874

Name: FDA 510(k) clearance K851874
Creator: U.S. Food and Drug Administration
Published: 1985-08-08

Substantially Equivalent

Kinetic Concepts, Inc.

FDA 510(k) clearance K851874 for OR TUBE RESTRAINT, Substantially Equivalent on 1985-08-08. Applicant: Kinetic Concepts, Inc.. Device class: 1.

Clearance details

Applicant: Kinetic Concepts, Inc.
Product code: Code CBH
Device class: Class 1
Regulation: 21 CFR 868.5770
Advisory panel: Anesthesiology
Date received: 1985-04-29
Decision date: 1985-08-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Antonio, TX, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code CBH

product code CBH

Death: 7
Total: 7

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.