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Access NT-proBNP (K262109): 510(k) cleared for Beckman Coulter, Inc. vs Access BNP II (K262597): 510(k) cleared for Beckman Coulter, Inc.: FDAPulse comparison
Access NT-proBNP (K262109): 510(k) cleared for Beckman Coulter, Inc.'s review days of 90 is 1.1x Access BNP II (K262597): 510(k) cleared for Beckman Coulter, Inc.'s 85 (31st percentile). Access NT-proBNP (K262109): 510(k) cleared for Beckman Coulter, Inc. is dated 2026-09-21; Access BNP II (K262597): 510(k) cleared for Beckman Coulter, Inc. 2026-10-20.
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 Access NT-proBNP (K262109): 510(k) cleared for Beckman Coulter, Inc. compare to Access BNP II (K262597): 510(k) cleared for Beckman Coulter, Inc.?
| Field | Access NT-proBNP (K262109): 510(k) cleared for Beckman Coulter, Inc. | Access BNP II (K262597): 510(k) cleared for Beckman Coulter, Inc. |
|---|---|---|
| Record | 510(k) clearance | 510(k) clearance |
| 510(k) number | K262109 | K262597 |
| Device | Access NT-proBNP | Access BNP II |
| Applicant | Beckman Coulter, Inc. | Beckman Coulter, Inc. |
| Specialty / panel | Clinical Chemistry | Clinical Chemistry |
| Product code | NBC | NBC |
| Device class | 2 | 2 |
| Clearance type | Traditional | Traditional |
| Decision | Substantially Equivalent | Substantially Equivalent |
| Received | 2026-06-23 | 2026-07-27 |
| Decision date | 2026-09-21 | 2026-10-20 |
| Review time (days) | 90 | 85 |
| Third-party review | No | No |
| Applicant location | Chaska, MN, US | Chaska, MN, US |
| amount percentile | 31st | 25th |
| Predicate Speed & CAPA Advisory Opportunity Score | 36/100 | 36/100 |
| Peer rank and all 500 records (CSV) | 🔒 Click to unlock → | |
| Official source URLs for every peer record | 🔒 Click to unlock → | |
Official records: Access NT-proBNP (K262109): 510(k) cleared for Beckman Coulter, Inc. · Access BNP II (K262597): 510(k) cleared for Beckman Coulter, Inc.
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