Solution Set with 1.2 Micron Air Eliminating Filter— 510(k) K161808

Substantially Equivalent

Baxter Healthcare Corporation

FDA 510(k) clearance K161808 for Solution Set with 1.2 Micron Air Eliminating Filter, Substantially Equivalent on 2017-06-21. Applicant: Baxter Healthcare Corporation.

Clearance details

Applicant: Baxter Healthcare Corporation
Product code: Code FPA
Advisory panel: General Hospital
Date received: 2016-07-01
Decision date: 2017-06-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Round Lake, IL, US

Download summary PDF View on FDA.gov ↗

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.