INFUSITE NEEDLELESS ACCES DEVICE (STERILE, BULK NON-STERILE) AND INFUSITE NEEDLELESS ACCESS DEVICE 'Y' ADAPTER (BULK...— 510(k) K112073

Substantially Equivalent

Rx Devices, LLC

FDA 510(k) clearance K112073 for INFUSITE NEEDLELESS ACCES DEVICE (STERILE, BULK NON-STERILE) AND INFUSITE NEEDLELESS ACCESS DEVICE 'Y' ADAPTER (BULK..., Substantially Equivalent on 2012-04-11. Applicant: Rx Devices, LLC.

Clearance details

Applicant: Rx Devices, LLC
Product code: Code FPA
Advisory panel: General Hospital
Date received: 2011-07-20
Decision date: 2012-04-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Landrum, SC, US

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Adverse events under product code FPA

product code FPA

Death: 95
Injury: 14,421
Malfunction: 125,815
Other: 30
Total: 140,361

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.