PROFILE, A CRITICAL CARE LOW AIR LOSS BED— 510(k) K901901

Name: FDA 510(k) clearance K901901
Creator: U.S. Food and Drug Administration
Published: 1990-10-03

Substantially Equivalent

Kinetic Concepts, Inc.

FDA 510(k) clearance K901901 for PROFILE, A CRITICAL CARE LOW AIR LOSS BED, Substantially Equivalent on 1990-10-03. Applicant: Kinetic Concepts, Inc.. Device class: 2.

Clearance details

Applicant: Kinetic Concepts, Inc.
Product code: Code FNM
Device class: Class 2
Regulation: 21 CFR 880.5550
Advisory panel: General Hospital
Date received: 1990-04-27
Decision date: 1990-10-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Antonio, TX, US

Download summary PDF View on FDA.gov ↗

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K022011 — V.A.C. ABDOMINAL DRESSING2003-02-26
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Adverse events under product code FNM

product code FNM

Death: 22
Injury: 349
Other: 4
Total: 375

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.