SOL-CARE IV Bag Safety Connector— 510(k) K202732

Substantially Equivalent

Sol-Millennium Medical Group

FDA 510(k) clearance K202732 for SOL-CARE IV Bag Safety Connector, Substantially Equivalent on 2021-11-03. Applicant: Sol-Millennium Medical Group.

Clearance details

Applicant: Sol-Millennium Medical Group
Product code: Code LHI
Advisory panel: General Hospital
Date received: 2020-09-18
Decision date: 2021-11-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Suwanee, GA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code LHI

product code LHI

Injury: 207
Malfunction: 7,820
Other: 3
Total: 8,030

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.