nSet+ Stabilization Set [6426733]; nSet+ Stabilization Set with nSyte Needle Free Connector (NFC) [6426731]; nSyte Needle Free Connector (NFC) [6426727]— 510(k) K251257

Substantially Equivalent

Np Medical

FDA 510(k) clearance K251257 for nSet+ Stabilization Set [6426733]; nSet+ Stabilization Set with nSyte Needle Free Connector (NFC) [6426731]; nSyte Needle Free Connector (NFC) [6426727], Substantially Equivalent on 2025-12-04. Applicant: Np Medical.

Clearance details

Applicant: Np Medical
Product code: Code FPA
Advisory panel: General Hospital
Date received: 2025-04-23
Decision date: 2025-12-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Clinton, MA, 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.