Amsino International, Inc. · Class II · Cleared May 4, 2026
| K-number | K252543 |
| Device name | AMSafe Administration Set (BA-70075, BA-70071-D, BA-70070, BA-70071-P, BA-70072, BA-70072-F, BA-70071-DF, BA-70071-DF-120, FE01, FE04) |
| Applicant | Amsino International, Inc. |
| Product code | FPA |
| Device class | Class II |
| Decision date | May 4, 2026 |
| Decision | Substantially Equivalent |
| Regulation | 880.5440 |
The AMSafe Administration Set is a single-use, latex-free, sterile device used to deliver fluids intravenously to patients 18 years or older. It can be used with Zyno Z-800F/Z-800WF infusion pumps or by gravity flow in healthcare facilities, skilled nursing facilities, rehabilitation facilities, and home settings.
The subject device is substantially similar to the predicate (Zyno Medical Administration Sets K120685) in operating principle, sterilization (EtO, SAL 10⁻⁶), shelf life (3 years), and most components. Minor differences include alternative suppliers for some components, different shapes/colors for spike, drip chamber, and needleless Y-sites (all industry-standard per ISO 8536-4), and absence of a pressure-activated valve in the subject device.
ISO 8536-4, ISO 8536-8, ANSI/AAMI CN27, USP <788>, USP <71>, USP <85>, ISO 11135, ISO 11607, ASTM D4169, ASTM F1980, ISO 10993-1, AAMI TIR101:2021.
The subject device has identical intended use, principles of operation, and regulatory classification as the predicate. Component differences do not introduce new safety or effectiveness concerns, as demonstrated by bench performance testing, biocompatibility testing, pump compatibility testing, and accelerated aging studies. All performance metrics (flow rate accuracy, leakage, sterility, stability) fall within acceptable ranges equivalent to the predicate device.
View the full FDA submission: accessdata.fda.gov