MeCare Alpha (MCA2019)— 510(k) K260426
Substantially EquivalentIVT Medical, Ltd.
FDA 510(k) clearance K260426 for MeCare Alpha (MCA2019), Substantially Equivalent on 2026-10-08. Applicant: IVT Medical, Ltd.. Device class: 2.
Summary
MeCare Alpha, model MCA2019, is a negative pressure wound therapy pump from IVT Medical. Product code OMP covers negative pressure wound therapy powered suction pumps.
Class II, 21 CFR 878.4780. The General and Plastic Surgery panel reviewed it as a Traditional 510(k).
IVT Medical filed from Ra'anana, Israel. Review took 240 days (February 10 to October 8, 2026).
Clearance details
- Applicant
- IVT Medical, Ltd.
- Product code
- Product code OMP
- Device class
- Class 2
- Regulation
- 21 CFR 878.4780
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Ra'Anana, IL
Recent devices under product code OMP
view allMore clearances from IVT Medical, Ltd.
view allAdverse events under product code OMP
product code OMP- Death
- 31
- Injury
- 1,707
- Malfunction
- 4,047
- Other
- 1
- Total
- 5,786
Source: openFDA MAUDE database, through . 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.