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=K260315

cCeLL - In vivo (K260315): 510(k) cleared for VPIX Medical, Inc.

Q: How to monitor cCeLL - In vivo (K260315): 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.

cCeLL - In vivo (K260315): 510(k) cleared for VPIX Medical, Inc.: 510(k) cleared for VPIX Medical, Inc. Its amount of 259 is above the median of 138 (82nd percentile). Dated 19 days ago, it is in the active follow-up window. 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: 259 · 82th percentile of 414 FDAPulse records · 1.9x 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	K260315
Device	cCeLL - In vivo
Applicant	VPIX Medical, Inc.
Specialty / panel	Neurology
Product code	GWG
Device class	2
Clearance type	Traditional
Decision	Substantially Equivalent
Received	2026-01-30
Decision date	2026-10-16
Review time (days)	259
Third-party review	No
Applicant location	Daejeon, KR
amount percentile	82th of 414 (median 138, 1.9x median)
Peer records CSV (32 KR records)	🔒 Click to unlock →
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: 2026-10-16
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: cCeLL - In vivo (K260315): 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
cCeLL - In vivo (K260315): 510(k) cleared for VPIX Medical, Inc.'s amount: 82nd percentile of 414 records
Timing: Medium: dated in the last 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 259-day review suggests additional-information requests: a firm likely to value regulatory help next time.
Posted 19 days ago.

What is the FDAPulse record for cCeLL - In vivo (K260315): 510(k) cleared for VPIX Medical, Inc.?

cCeLL - In vivo (K260315) by VPIX Medical, Inc. was cleared on 2026-10-16 after 259 days of review.

How does cCeLL - In vivo (K260315): 510(k) cleared for VPIX Medical, Inc. compare to other FDAPulse records?

Its amount of 259 sits in the upper half (82th percentile) of 414 records; the median is 138. It is 19 days old, still within a typical 45-day follow-up window.

cCeLL - In vivo (K260315) vs. top 3 peers

Organization	Location	Record date
cCeLL - In vivo (K260315)	KR	2026-10-16
7D Surgical System (10-0001) (K260403)	CA	2026-10-19
Neurora (K260064)	NH	2026-10-02
Ventricular Catheters, Thomale Catheter (K260044)	PA	2026-10-02

How to monitor cCeLL - In vivo (K260315): 510(k) cleared for VPIX Medical, Inc. and peer neurology records

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