FAQ (FAQ 411) (K261565): 510(k) cleared for Foreo, Inc.
FAQ (FAQ 411) (K261565): 510(k) cleared for Foreo, Inc. (Nevada): 510(k) cleared for Foreo, Inc. Its amount of 164 is above the median of 138 (59th percentile). Dated 13 days ago, it is in the active follow-up window. Score 54/100. As of 2026-11-04, from U.S. FDA openFDA (510(k) clearances and device enforcement reports).
Data as of · Compiled by Zalwin from U.S. FDA openFDA (510(k) clearances and device enforcement reports)
amount: 164 · 59th percentile of 414 FDAPulse records · 1.2x the median
Free preview: all 14 published fields of this record are shown below. Locked: 1 related NV FDAPulse records and the 5-column CSV export.
| Field | Value |
|---|---|
| Record | 510(k) clearance |
| 510(k) number | K261565 |
| Device | FAQ (FAQ 411) |
| Applicant | Foreo, Inc. |
| Specialty / panel | Neurology |
| Product code | NFO |
| Device class | 2 |
| Clearance type | Traditional |
| Decision | Substantially Equivalent |
| Received | 2026-05-11 |
| Decision date | 2026-10-22 |
| Review time (days) | 164 |
| Third-party review | No |
| Applicant location | Las Vegas, NV, US |
| amount percentile | 59th of 414 (median 138, 1.2x median) |
| Peer records CSV (2 NV records) | 🔒 Click to unlock → |
| CRM-ready export with official source URLs | 🔒 Click to unlock → |
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CSV columns: Record · Specialty · Date · Review days · Recall class · official source URL
- Source agency: U.S. FDA openFDA (510(k) clearances and device enforcement reports)
- Record date: 2026-10-22
- Data refreshed: 2026-11-04
- Refunds on request within 14 days
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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: FAQ (FAQ 411) (K261565): 510(k) cleared for Foreo, Inc. and 2 Nevada peers
- Nevada FDAPulse records like this one: 2
- FAQ (FAQ 411) (K261565): 510(k) cleared for Foreo, Inc.'s amount: 59th percentile of 414 records
- Timing: Medium: dated in the last 30 days
- Estimated pipeline if you contact every Nevada peer: $400 (peers × rate × deal size; an estimate from your assumptions, not a forecast)
54 / 100 Predicate Speed & CAPA Advisory Opportunity Score
- 164-day review, longer than typical.
- Posted 13 days ago.
What is the FDAPulse record for FAQ (FAQ 411) (K261565): 510(k) cleared for Foreo, Inc. in Nevada?
FAQ (FAQ 411) (K261565) by Foreo, Inc. was cleared on 2026-10-22 after 164 days of review.
How does FAQ (FAQ 411) (K261565): 510(k) cleared for Foreo, Inc. compare to other Nevada FDAPulse records?
Its amount of 164 sits in the upper half (59th percentile) of 414 records; the median is 138. It is fresh: dated 13 days ago, inside the window where early outreach matters most.
FAQ (FAQ 411) (K261565) vs. top 3 peers
| Organization | Location | Record date |
|---|---|---|
| FAQ (FAQ 411) (K261565) | NV | 2026-10-22 |
| 7D Surgical System (10-0001) (K260403) | CA | 2026-10-19 |
| cCeLL - In vivo (K260315) | KR | 2026-10-16 |
| Neurora (K260064) | NH | 2026-10-02 |
Compare FAQ (FAQ 411) (K261565) vs Sleep Analysis Module (K261521) →
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