# Disposable Reflective Marker Spheres (AM-BK115S, AM-BL130S) (K262214): 510(k) cleared for Guangzhou Aimooe Technology Co., Ltd.

**Predicate Speed & CAPA Advisory Opportunity Score:** 36/100

| Field | Value |
|---|---|
| Record | 510(k) clearance |
| 510(k) number | K262214 |
| Device | Disposable Reflective Marker Spheres (AM-BK115S, AM-BL130S) |
| Applicant | Guangzhou Aimooe Technology Co., Ltd. |
| Specialty / panel | Neurology |
| Product code | HAW |
| Device class | 2 |
| Clearance type | Traditional |
| Decision | Substantially Equivalent |
| Received | 2026-06-30 |
| Decision date | 2026-10-15 |
| Review time (days) | 107 |
| Third-party review | No |
| Applicant location | Guangzhou, CN |

## Why this score
- Fast 107-day review: this device is a strong predicate for similar products.
- Posted 21 days ago.

Source: U.S. FDA openFDA (510(k) clearances and device enforcement reports) (https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K262214). Last refreshed: 2026-11-04T21:30:53.898Z.
Data from the FDA openFDA API, which may lag official FDA databases. Informational only; not regulatory or legal advice.