ECG Analysis Software (AiTiALVSD) (K254302): 510(k) cleared for Medical AI Co., Ltd.
ECG Analysis Software (AiTiALVSD) (K254302): 510(k) cleared for Medical AI Co., Ltd.: 510(k) cleared for Medical AI Co., Ltd. Its amount of 273 is top-decile (95th percentile of 414 records). Dated 35 days ago, it serves as a historical benchmark. Score 61/100. As of 2026-11-03, from U.S. FDA openFDA (510(k) clearances and device enforcement reports).
Data as of · Compiled by Zalwin from U.S. FDA openFDA (510(k) clearances and device enforcement reports)
amount: 273 · 95th percentile of 414 FDAPulse records · 2.0x the median
Free preview: all 14 published fields of this record are shown below. Locked: 31 related KR FDAPulse records and the 5-column CSV export.
| Field | Value |
|---|---|
| Record | 510(k) clearance |
| 510(k) number | K254302 |
| Device | ECG Analysis Software (AiTiALVSD) |
| Applicant | Medical AI Co., Ltd. |
| Specialty / panel | Cardiovascular |
| Product code | QYE |
| Device class | 2 |
| Clearance type | Traditional |
| Decision | Substantially Equivalent |
| Received | 2025-12-31 |
| Decision date | 2026-09-30 |
| Review time (days) | 273 |
| Third-party review | No |
| Applicant location | Gangnam-Gu, Seoul, KR |
| amount percentile | 95th of 414 (median 138, 2.0x median) |
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CSV columns: Record · Specialty · Date · Review days · Recall class · official source URL
- Source agency: U.S. FDA openFDA (510(k) clearances and device enforcement reports)
- Record date: 2026-09-30
- Data refreshed: 2026-11-03
- Refunds on request within 14 days
Top FDAPulse records (KR first): cCeLL405 (K254030) · REBOHIL (BGM-1, BGM-2, BGM-3, BGM-4, BGM-5) (K254210) · S-Patch CardioAI (K254255) · PicoreMax (PicoreMax) (K254199) · Dia-X Sil Light Body (K254152) · Browse all by state and category →
LIVE PUBLIC DATA Source: U.S. FDA openFDA (510(k) clearances and device enforcement reports) · Last refreshed: Tue, 03 Nov 2026 18:05:14 GMT
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Peer benchmark and outreach value: ECG Analysis Software (AiTiALVSD) (K254302): 510(k) cleared for Medical AI Co., Ltd. and 32 KR peers
- KR FDAPulse records like this one: 32
- ECG Analysis Software (AiTiALVSD) (K254302): 510(k) cleared for Medical AI Co., Ltd.'s amount: 95th percentile of 414 records
- Timing: Low: older than 30 days
- Estimated pipeline if you contact every KR peer: $6,400 (peers × rate × deal size; an estimate from your assumptions, not a forecast)
61 / 100 Predicate Speed & CAPA Advisory Opportunity Score
- A long 273-day review suggests additional-information requests: a firm likely to value regulatory help next time.
- Posted 35 days ago.
What is the FDAPulse record for ECG Analysis Software (AiTiALVSD) (K254302): 510(k) cleared for Medical AI Co., Ltd.?
ECG Analysis Software (AiTiALVSD) (K254302) by Medical AI Co., Ltd. was cleared on 2026-09-30 after 273 days of review.
How does ECG Analysis Software (AiTiALVSD) (K254302): 510(k) cleared for Medical AI Co., Ltd. compare to other FDAPulse records?
This is a top-decile record: its amount of 273 is 2.0x the median of 138 across 414 records. It is 35 days old, still within a typical 45-day follow-up window.
ECG Analysis Software (AiTiALVSD) (K254302) vs. top 3 peers
| Organization | Location | Record date |
|---|---|---|
| ECG Analysis Software (AiTiALVSD) (K254302) | KR | 2026-09-30 |
| Hemotag Analysis Software (HAS) (K252736) | FL | 2026-10-21 |
| TriSalus TriNav Advance Infusion System (K253509) | CO | 2026-09-21 |
| Small Diameter Core Wire (CMAN-000-00); Small Diameter Core Wire (CMAN-000-14) (K260168) | TX | 2026-10-16 |
Compare ECG Analysis Software (AiTiALVSD) (K254302) vs S-Patch CardioAI (K254255) →
Related records
- Hemotag Analysis Software (HAS) (K252736): 510(k) cleared for Aventusoft, LLC
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- S-Patch CardioAI (K254255): 510(k) cleared for Wellysis Corp.
- Tempus ECG-MR (K254297): 510(k) cleared for Tempus AI, Inc.
- Echo-2 (K254240): 510(k) cleared for Neko Health AB
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Recent FDA 510(k) clearances FDA 510(k) clearances and recalls: Cardiovascular devices
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