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S-Patch CardioAI (K254255): 510(k) cleared for Wellysis Corp. vs ECG Analysis Software (AiTiALVSD) (K254302): 510(k) cleared for Medical AI Co., Ltd.: FDAPulse comparison

ECG Analysis Software (AiTiALVSD) (K254302): 510(k) cleared for Medical AI Co., Ltd.'s review days of 273 is 1.0x S-Patch CardioAI (K254255): 510(k) cleared for Wellysis Corp.'s 270 (95th percentile). S-Patch CardioAI (K254255): 510(k) cleared for Wellysis Corp. is dated 2026-09-25; ECG Analysis Software (AiTiALVSD) (K254302): 510(k) cleared for Medical AI Co., Ltd. 2026-09-30.

Data as of · Compiled by Zalwin from U.S. FDA openFDA (510(k) clearances and device enforcement reports)

Both records plus every comparable record, with all columns and source links · Card, Apple Pay, Google Pay or Link via Stripe

How does S-Patch CardioAI (K254255): 510(k) cleared for Wellysis Corp. compare to ECG Analysis Software (AiTiALVSD) (K254302): 510(k) cleared for Medical AI Co., Ltd.?

FieldS-Patch CardioAI (K254255): 510(k) cleared for Wellysis Corp.ECG Analysis Software (AiTiALVSD) (K254302): 510(k) cleared for Medical AI Co., Ltd.
Record510(k) clearance510(k) clearance
510(k) numberK254255K254302
DeviceS-Patch CardioAIECG Analysis Software (AiTiALVSD)
ApplicantWellysis Corp.Medical AI Co., Ltd.
Specialty / panelCardiovascularCardiovascular
Product codeDQKQYE
Device class22
Clearance typeTraditionalTraditional
DecisionSubstantially EquivalentSubstantially Equivalent
Received2025-12-292025-12-31
Decision date2026-09-252026-09-30
Review time (days)270273
Third-party reviewNoNo
Applicant locationSeoul, KRGangnam-Gu, Seoul, KR
amount percentile94th95th
Predicate Speed & CAPA Advisory Opportunity Score61/10061/100
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Official records: S-Patch CardioAI (K254255): 510(k) cleared for Wellysis Corp. · ECG Analysis Software (AiTiALVSD) (K254302): 510(k) cleared for Medical AI Co., Ltd.

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Data from the FDA openFDA API, which may lag official FDA databases. Informational only; not regulatory or legal advice.

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