Where does the data come from?

U.S. FDA openFDA (510(k) clearances and device enforcement reports). Official record: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K254255

S-Patch CardioAI (K254255): 510(k) cleared for Wellysis Corp.

Q: How to monitor S-Patch CardioAI (K254255): 510(k) cleared for Wellysis Corp. and peer cardiovascular records

FDAPulse lists new FDAPulse records from U.S. FDA openFDA (510(k) clearances and device enforcement reports) as they are published; a free weekly email digest and paid alerts follow records like this one.

S-Patch CardioAI (K254255): 510(k) cleared for Wellysis Corp.: 510(k) cleared for Wellysis Corp. Its amount of 270 is top-decile (94th percentile of 414 records). Dated 41 days ago, it serves as a historical benchmark. Score 61/100. As of 2026-11-04, from U.S. FDA openFDA (510(k) clearances and device enforcement reports).

Data as of 2026-11-04 · Compiled by Zalwin from U.S. FDA openFDA (510(k) clearances and device enforcement reports)

amount: 270 · 94th 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	K254255
Device	S-Patch CardioAI
Applicant	Wellysis Corp.
Specialty / panel	Cardiovascular
Product code	DQK
Device class	2
Clearance type	Traditional
Decision	Substantially Equivalent
Received	2025-12-29
Decision date	2026-09-25
Review time (days)	270
Third-party review	No
Applicant location	Seoul, KR
amount percentile	94th of 414 (median 138, 2.0x median)
Peer records CSV (32 KR records)	🔒 Click to unlock →
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Source agency: U.S. FDA openFDA (510(k) clearances and device enforcement reports)
Record date: 2026-09-25
Data refreshed: 2026-11-04
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LIVE PUBLIC DATA Source: U.S. FDA openFDA (510(k) clearances and device enforcement reports) · Last refreshed: Wed, 04 Nov 2026 09:16:12 GMT

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Peer benchmark and outreach value: S-Patch CardioAI (K254255): 510(k) cleared for Wellysis Corp. and 32 KR peers

Your role Typical deal size (USD) Assumed reply-to-deal rate (%)

KR FDAPulse records like this one: 32
S-Patch CardioAI (K254255): 510(k) cleared for Wellysis Corp.'s amount: 94th 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 270-day review suggests additional-information requests: a firm likely to value regulatory help next time.
Posted 41 days ago.

What is the FDAPulse record for S-Patch CardioAI (K254255): 510(k) cleared for Wellysis Corp.?

S-Patch CardioAI (K254255) by Wellysis Corp. was cleared on 2026-09-25 after 270 days of review.

How does S-Patch CardioAI (K254255): 510(k) cleared for Wellysis Corp. compare to other FDAPulse records?

This is a top-decile record: its amount of 270 is 2.0x the median of 138 across 414 records. It is 41 days old, still within a typical 45-day follow-up window.

S-Patch CardioAI (K254255) vs. top 3 peers

Organization	Location	Record date
S-Patch CardioAI (K254255)	KR	2026-09-25
TriSalus TriNav Advance Infusion System (K253509)	CO	2026-09-21
Hemotag Analysis Software (HAS) (K252736)	FL	2026-10-21
Small Diameter Core Wire (CMAN-000-00); Small Diameter Core Wire (CMAN-000-14) (K260168)	TX	2026-10-16

How to monitor S-Patch CardioAI (K254255): 510(k) cleared for Wellysis Corp. and peer cardiovascular records

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