Neurora (K260064): 510(k) cleared for Argus Cognitive, Inc.
Neurora (K260064): 510(k) cleared for Argus Cognitive, Inc. (New Hampshire): 510(k) cleared for Argus Cognitive, Inc. Its amount of 266 is above the median of 138 (86th percentile). Dated 33 days ago, it serves as a historical benchmark. Score 61/100. 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: 266 · 86th percentile of 414 FDAPulse records · 1.9x the median
Free preview: all 14 published fields of this record are shown below. Locked: 1 related NH FDAPulse records and the 5-column CSV export.
| Field | Value |
|---|---|
| Record | 510(k) clearance |
| 510(k) number | K260064 |
| Device | Neurora |
| Applicant | Argus Cognitive, Inc. |
| Specialty / panel | Neurology |
| Product code | QPF |
| Device class | 2 |
| Clearance type | Traditional |
| Decision | Substantially Equivalent |
| Received | 2026-01-09 |
| Decision date | 2026-10-02 |
| Review time (days) | 266 |
| Third-party review | No |
| Applicant location | Hanover, NH, US |
| amount percentile | 86th of 414 (median 138, 1.9x median) |
| Peer records CSV (2 NH 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: 2026-10-02
- 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: Neurora (K260064): 510(k) cleared for Argus Cognitive, Inc. and 2 New Hampshire peers
- New Hampshire FDAPulse records like this one: 2
- Neurora (K260064): 510(k) cleared for Argus Cognitive, Inc.'s amount: 86th percentile of 414 records
- Timing: Low: older than 30 days
- Estimated pipeline if you contact every New Hampshire peer: $400 (peers × rate × deal size; an estimate from your assumptions, not a forecast)
61 / 100 Predicate Speed & CAPA Advisory Opportunity Score
- A long 266-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 Neurora (K260064): 510(k) cleared for Argus Cognitive, Inc. in New Hampshire?
Neurora (K260064) by Argus Cognitive, Inc. was cleared on 2026-10-02 after 266 days of review.
How does Neurora (K260064): 510(k) cleared for Argus Cognitive, Inc. compare to other New Hampshire FDAPulse records?
Its amount of 266 sits in the upper half (86th percentile) of 414 records; the median is 138. It is 33 days old, still within a typical 45-day follow-up window.
Neurora (K260064) vs. top 3 peers
| Organization | Location | Record date | Compare |
|---|---|---|---|
| Neurora (K260064) | NH | 2026-10-02 | This record |
| 7D Surgical System (10-0001) (K260403) | CA | 2026-10-19 | View record → |
| cCeLL - In vivo (K260315) | KR | 2026-10-16 | View record → |
| Ventricular Catheters, Thomale Catheter (K260044) | PA | 2026-10-02 | Compare Neurora (K260064) vs Ventricular Catheters, Thomale Catheter (K260044) → |
Compare Neurora (K260064) vs Disposable Sterile Skull Drill (LZ) (K254177) →
Related records
- 7D Surgical System (10-0001) (K260403): 510(k) cleared for 7D Surgical ULC
- cCeLL - In vivo (K260315): 510(k) cleared for VPIX Medical, Inc.
- Ventricular Catheters, Thomale Catheter (K260044): 510(k) cleared for Aesculap, Inc.
- cCeLL405 (K254030): 510(k) cleared for VPIX Medical, Inc.
- Durashield Device Kit (K252995): 510(k) cleared for SurGenTec, LLC
- Disposable Sterile Skull Drill (LZ) (K254177): 510(k) cleared for Guizhou Zirui Technology Co., Ltd.
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