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=K254030

cCeLL405 (K254030): 510(k) cleared for VPIX Medical, Inc.

Q: How to monitor cCeLL405 (K254030): 510(k) cleared for VPIX Medical, Inc. and peer neurology 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.

cCeLL405 (K254030): 510(k) cleared for VPIX Medical, Inc.: 510(k) cleared for VPIX Medical, Inc. Its amount of 290 is top-decile (96th percentile of 414 records). Dated 33 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 2026-11-03 · Compiled by Zalwin from U.S. FDA openFDA (510(k) clearances and device enforcement reports)

amount: 290 · 96th percentile of 414 FDAPulse records · 2.1x 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	K254030
Device	cCeLL405
Applicant	VPIX Medical, Inc.
Specialty / panel	Neurology
Product code	QFX
Device class	2
Clearance type	Traditional
Decision	Substantially Equivalent
Received	2025-12-16
Decision date	2026-10-02
Review time (days)	290
Third-party review	No
Applicant location	Daejeon, KR
amount percentile	96th of 414 (median 138, 2.1x median)
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CRM-ready export with official source URLs	🔒 Click to unlock →

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Source agency: U.S. FDA openFDA (510(k) clearances and device enforcement reports)
Record date: 2026-10-02
Data refreshed: 2026-11-03
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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: cCeLL405 (K254030): 510(k) cleared for VPIX Medical, Inc. and 32 KR peers

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

KR FDAPulse records like this one: 32
cCeLL405 (K254030): 510(k) cleared for VPIX Medical, Inc.'s amount: 96th 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 290-day review suggests additional-information requests: a firm likely to value regulatory help next time.
Posted 33 days ago.

What is the FDAPulse record for cCeLL405 (K254030): 510(k) cleared for VPIX Medical, Inc.?

cCeLL405 (K254030) by VPIX Medical, Inc. was cleared on 2026-10-02 after 290 days of review.

How does cCeLL405 (K254030): 510(k) cleared for VPIX Medical, Inc. compare to other FDAPulse records?

This is a top-decile record: its amount of 290 is 2.1x the median of 138 across 414 records. It is 33 days old, still within a typical 45-day follow-up window.

cCeLL405 (K254030) vs. top 3 peers

Organization	Location	Record date
cCeLL405 (K254030)	KR	2026-10-02
7D Surgical System (10-0001) (K260403)	CA	2026-10-19
cCeLL - In vivo (K260315)	KR	2026-10-16
Neurora (K260064)	NH	2026-10-02

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