KLARITY VACUUM BAG, KLARITY MOLD CUSHION— 510(k) K132124

Substantially Equivalent

Klarity Medical Products, LLC

FDA 510(k) clearance K132124 for KLARITY VACUUM BAG, KLARITY MOLD CUSHION, Substantially Equivalent on 2013-11-01. Applicant: Klarity Medical Products, LLC.

Clearance details

Applicant: Klarity Medical Products, LLC
Product code: Code IYE
Advisory panel: Radiology
Date received: 2013-07-10
Decision date: 2013-11-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Newark, OH, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code IYE

product code IYE

Malfunction: 455
Other: 3
Total: 458

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.