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=K254240

Echo-2 (K254240): 510(k) cleared for Neko Health AB

Q: How to monitor Echo-2 (K254240): 510(k) cleared for Neko Health AB and peer cardiovascular records

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Echo-2 (K254240): 510(k) cleared for Neko Health AB: 510(k) cleared for Neko Health AB. Its amount of 267 is above the median of 138 (88th percentile). Dated 43 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: 267 · 88th percentile of 414 FDAPulse records · 1.9x the median

Free preview: all 14 published fields of this record are shown below. Locked: 1 related SE FDAPulse records and the 5-column CSV export.

Field	Value
Record	510(k) clearance
510(k) number	K254240
Device	Echo-2
Applicant	Neko Health AB
Specialty / panel	Cardiovascular
Product code	QOK
Device class	2
Clearance type	Traditional
Decision	Substantially Equivalent
Received	2025-12-29
Decision date	2026-09-22
Review time (days)	267
Third-party review	No
Applicant location	Danderyd, SE
amount percentile	88th of 414 (median 138, 1.9x median)
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Source agency: U.S. FDA openFDA (510(k) clearances and device enforcement reports)
Record date: 2026-09-22
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: Echo-2 (K254240): 510(k) cleared for Neko Health AB and 2 SE peers

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

SE FDAPulse records like this one: 2
Echo-2 (K254240): 510(k) cleared for Neko Health AB's amount: 88th percentile of 414 records
Timing: Low: older than 30 days
Estimated pipeline if you contact every SE peer: $400 (peers × rate × deal size; an estimate from your assumptions, not a forecast)

61 / 100 Predicate Speed & CAPA Advisory Opportunity Score

A long 267-day review suggests additional-information requests: a firm likely to value regulatory help next time.
Posted 43 days ago.

What is the FDAPulse record for Echo-2 (K254240): 510(k) cleared for Neko Health AB?

Echo-2 (K254240) by Neko Health AB was cleared on 2026-09-22 after 267 days of review.

How does Echo-2 (K254240): 510(k) cleared for Neko Health AB compare to other FDAPulse records?

Its amount of 267 sits in the upper half (88th percentile) of 414 records; the median is 138. It is 43 days old, still within a typical 45-day follow-up window.

Echo-2 (K254240) vs. top 3 peers

Organization	Location	Record date
Echo-2 (K254240)	SE	2026-09-22
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

How to monitor Echo-2 (K254240): 510(k) cleared for Neko Health AB and peer cardiovascular records

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