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FDA 510(k)

MeCare Alpha (MCA2019)

K-Number: K260426 · 2026-10-08

ApplicantIVT Medical, Ltd.
Decision Date2026-10-08
Product CodeOMP
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

MeCare Alpha (MCA2019) is the device name listed in this FDA 510(k) record. The listed applicant is IVT Medical, Ltd.. It received FDA 510(k) clearance on 2026-10-08 under 510(k) number K260426. The device is classified under product code OMP. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MeCare Alpha (MCA2019)?

MeCare Alpha (MCA2019) is a medical device that received FDA 510(k) clearance on 2026-10-08. The listed applicant is IVT Medical, Ltd.. The 510(k) number is K260426.

When did MeCare Alpha (MCA2019) receive FDA 510(k) clearance?

MeCare Alpha (MCA2019) received FDA 510(k) clearance on 2026-10-08, under 510(k) number K260426.

Who is the listed applicant for MeCare Alpha (MCA2019)?

The FDA 510(k) record lists IVT Medical, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MeCare Alpha (MCA2019)?

The FDA product code for MeCare Alpha (MCA2019) is OMP.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT04745156A Study Using Brain Stimulation and Behavioral Therapy to Increase Extent of Resection in Low-Grade GliomasNOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDED

Other records listing IVT Medical, Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K121817VCARE A

Related Devices (Code: OMP)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261338RENASYS DYNAFLOW Kit (66807741)Smith & Nephew Medical, Ltd.K253263ConvaVAC™ Negative Pressure Wound Therapy SystemConvatec Limited, Gdc BuildingK253199CURASYS 2 (EMDN0003)CG Bio Co., Ltd.K260646RENASYS EDGE (66803126)Smith & Nephew Medical, Ltd.K261291Nisus NPWT Canister 500-mL (CPC-500)Cork MedicalK254019Wound Geni NPWT SystemBechtel Medical, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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