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Disposable Sterile Skull Drill (LZ) (K254177): 510(k) cleared for Guizhou Zirui Technology Co., Ltd. vs Neurora (K260064): 510(k) cleared for Argus Cognitive, Inc.: FDAPulse comparison
Neurora (K260064): 510(k) cleared for Argus Cognitive, Inc.'s review days of 266 is 1.0x Disposable Sterile Skull Drill (LZ) (K254177): 510(k) cleared for Guizhou Zirui Technology Co., Ltd.'s 262 (86th percentile). Disposable Sterile Skull Drill (LZ) (K254177): 510(k) cleared for Guizhou Zirui Technology Co., Ltd. is dated 2026-09-11; Neurora (K260064): 510(k) cleared for Argus Cognitive, Inc. 2026-10-02.
Data as of · Compiled by Zalwin from U.S. FDA openFDA (510(k) clearances and device enforcement reports)
Both records plus every comparable record, with all columns and source links · Card, Apple Pay, Google Pay or Link via Stripe
How does Disposable Sterile Skull Drill (LZ) (K254177): 510(k) cleared for Guizhou Zirui Technology Co., Ltd. compare to Neurora (K260064): 510(k) cleared for Argus Cognitive, Inc.?
| Field | Disposable Sterile Skull Drill (LZ) (K254177): 510(k) cleared for Guizhou Zirui Technology Co., Ltd. | Neurora (K260064): 510(k) cleared for Argus Cognitive, Inc. |
|---|---|---|
| Record | 510(k) clearance | 510(k) clearance |
| 510(k) number | K254177 | K260064 |
| Device | Disposable Sterile Skull Drill (LZ) | Neurora |
| Applicant | Guizhou Zirui Technology Co., Ltd. | Argus Cognitive, Inc. |
| Specialty / panel | Neurology | Neurology |
| Product code | HBF | QPF |
| Device class | 2 | 2 |
| Clearance type | Traditional | Traditional |
| Decision | Substantially Equivalent | Substantially Equivalent |
| Received | 2025-12-23 | 2026-01-09 |
| Decision date | 2026-09-11 | 2026-10-02 |
| Review time (days) | 262 | 266 |
| Third-party review | No | No |
| Applicant location | Zunyi, CN | Hanover, NH, US |
| amount percentile | 84th | 86th |
| Predicate Speed & CAPA Advisory Opportunity Score | 55/100 | 61/100 |
| Peer rank and all 500 records (CSV) | 🔒 Click to unlock → | |
| Official source URLs for every peer record | 🔒 Click to unlock → | |
Official records: Disposable Sterile Skull Drill (LZ) (K254177): 510(k) cleared for Guizhou Zirui Technology Co., Ltd. · Neurora (K260064): 510(k) cleared for Argus Cognitive, Inc.
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