Microvention · Class II · Cleared Jun 13, 2025
| K-number | K243638 |
| Device name | MV Flow Aspiration Pump (MVFLOWPMP01) |
| Applicant | Microvention |
| Product code | JCX |
| Device class | Class II |
| Decision date | Jun 13, 2025 |
| Decision | Substantially Equivalent |
| Regulation | 878.4780 |
The MV Flow Aspiration Pump is an electrically powered device (100 VAC/50 Hz, 240 VAC/60 Hz) designed to generate vacuum pressure for general suction use in hospitals and clinics. It delivers a maximum vacuum pressure of 29 inHg with a maximum flow rate of 36 L/min, and is not intended for use in transport or field settings.
Both the subject device and predicate (Penumbra Pump MAX) are AC-powered diaphragm pumps that provide a maximum vacuum of 29 inHg. They share identical design, principle of operation, energy source, and performance specifications. Both are reusable devices with single-use pump canisters that accommodate up to 1000 mL of volume.
Nonclinical testing referenced FDA consensus standards including IEC 60601-1 (electrical safety), IEC 60601-1-2 (EMC/EMI compliance), ISO 10079-1 and ISO 10079-4 (device-specific pump standards), and FDA Guidance Document for Powered Suction Pump 510(k). Bench and operational-life testing were conducted per these standards.
The subject device shares identical technological characteristics with the predicate device, including design, operating principle, energy source, and performance specifications (both deliver 29 inHg maximum vacuum). Bench testing confirmed the subject device meets all specifications for electrical requirements, physical dimensions, maximum vacuum pressure, flow rate, and canister performance. Operational-life testing at 500 hours confirmed sustained specification compliance. The nonclinical testing demonstrated substantial equivalence of technological characteristics, and the benefit-risk assessment determined that differences in performance do not raise different safety or effectiveness questions.
View the full FDA submission: accessdata.fda.gov