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=K260096

Wishbone HAE (K260096): 510(k) cleared for Wishbone SA

Q: How to monitor Wishbone HAE (K260096): 510(k) cleared for Wishbone SA and peer dental records

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Wishbone HAE (K260096): 510(k) cleared for Wishbone SA: 510(k) cleared for Wishbone SA. Its amount of 269 is top-decile (93rd percentile of 414 records). Dated 26 days ago, it is in the active follow-up window. 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: 269 · 93th percentile of 414 FDAPulse records · 1.9x the median

Free preview: all 14 published fields of this record are shown below. Locked: 4 related BE FDAPulse records and the 5-column CSV export.

Field	Value
Record	510(k) clearance
510(k) number	K260096
Device	Wishbone HAE
Applicant	Wishbone SA
Specialty / panel	Dental
Product code	NPM
Device class	2
Clearance type	Traditional
Decision	Substantially Equivalent
Received	2026-01-13
Decision date	2026-10-09
Review time (days)	269
Third-party review	No
Applicant location	Flémalle, BE
amount percentile	93th of 414 (median 138, 1.9x 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: 2026-10-09
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: Wishbone HAE (K260096): 510(k) cleared for Wishbone SA and 5 BE peers

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

BE FDAPulse records like this one: 5
Wishbone HAE (K260096): 510(k) cleared for Wishbone SA's amount: 93rd percentile of 414 records
Timing: Medium: dated in the last 30 days
Estimated pipeline if you contact every BE peer: $1,000 (peers × rate × deal size; an estimate from your assumptions, not a forecast)

61 / 100 Predicate Speed & CAPA Advisory Opportunity Score

A long 269-day review suggests additional-information requests: a firm likely to value regulatory help next time.
Posted 26 days ago.

What is the FDAPulse record for Wishbone HAE (K260096): 510(k) cleared for Wishbone SA?

Wishbone HAE (K260096) by Wishbone SA was cleared on 2026-10-09 after 269 days of review.

How does Wishbone HAE (K260096): 510(k) cleared for Wishbone SA compare to other FDAPulse records?

This is a top-decile record: its amount of 269 is 1.9x the median of 138 across 414 records. It is 26 days old, still within a typical 45-day follow-up window.

Wishbone HAE (K260096) vs. top 3 peers

Organization	Location	Record date
Wishbone HAE (K260096)	BE	2026-10-09
LuxDesign (K260421)	IL	2026-10-23
Mobile Dental Solution (Model	CN	2026-10-23
Forza (K260136)	CA	2026-10-06

Compare Wishbone HAE (K260096) vs CMF Titanium Splints (K260913) →

How to monitor Wishbone HAE (K260096): 510(k) cleared for Wishbone SA and peer dental records

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