# MeCare Alpha (MCA2019) (K260426): 510(k) cleared for IVT Medical, Ltd.

**Predicate Speed & CAPA Advisory Opportunity Score:** 48/100

| Field | Value |
|---|---|
| Record | 510(k) clearance |
| 510(k) number | K260426 |
| Device | MeCare Alpha (MCA2019) |
| Applicant | IVT Medical, Ltd. |
| Specialty / panel | General, Plastic Surgery |
| Product code | OMP |
| Device class | 2 |
| Clearance type | Traditional |
| Decision | Substantially Equivalent |
| Received | 2026-02-10 |
| Decision date | 2026-10-08 |
| Review time (days) | 240 |
| Third-party review | No |
| Applicant location | Ra'Anana, IL |

## Why this score
- 240-day review, longer than typical.
- Posted 27 days ago.

Source: U.S. FDA openFDA (510(k) clearances and device enforcement reports) (https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260426). Last refreshed: 2026-11-03T18:05:14.713Z.
Data from the FDA openFDA API, which may lag official FDA databases. Informational only; not regulatory or legal advice.