# Access BNP II (K262597): 510(k) cleared for Beckman Coulter, Inc.

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

| Field | Value |
|---|---|
| Record | 510(k) clearance |
| 510(k) number | K262597 |
| Device | Access BNP II |
| Applicant | Beckman Coulter, Inc. |
| Specialty / panel | Clinical Chemistry |
| Product code | NBC |
| Device class | 2 |
| Clearance type | Traditional |
| Decision | Substantially Equivalent |
| Received | 2026-07-27 |
| Decision date | 2026-10-20 |
| Review time (days) | 85 |
| Third-party review | No |
| Applicant location | Chaska, MN, US |

## Why this score
- Fast 85-day review: this device is a strong predicate for similar products.
- Posted 16 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=K262597). Last refreshed: 2026-11-04T09:16:12.111Z.
Data from the FDA openFDA API, which may lag official FDA databases. Informational only; not regulatory or legal advice.