Access BNP II (K262597): 510(k) cleared for Beckman Coulter, Inc.
Access BNP II (K262597): 510(k) cleared for Beckman Coulter, Inc. (Minnesota): 510(k) cleared for Beckman Coulter, Inc. Its amount of 85 is below the median of 138 (25th percentile). Dated 15 days ago, it is in the active follow-up window. Score 36/100. 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: 85 · 25th percentile of 414 FDAPulse records · 0.6x the median
Free preview: all 14 published fields of this record are shown below. Locked: 11 related MN FDAPulse records and the 5-column CSV export.
| 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 |
| amount percentile | 25th of 414 (median 138, 0.6x median) |
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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: 2026-10-20
- 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: Access BNP II (K262597): 510(k) cleared for Beckman Coulter, Inc. and 12 Minnesota peers
- Minnesota FDAPulse records like this one: 12
- Access BNP II (K262597): 510(k) cleared for Beckman Coulter, Inc.'s amount: 25th percentile of 414 records
- Timing: Medium: dated in the last 30 days
- Estimated pipeline if you contact every Minnesota peer: $2,400 (peers × rate × deal size; an estimate from your assumptions, not a forecast)
36 / 100 Predicate Speed & CAPA Advisory Opportunity Score
- Fast 85-day review: this device is a strong predicate for similar products.
- Posted 15 days ago.
What is the FDAPulse record for Access BNP II (K262597): 510(k) cleared for Beckman Coulter, Inc. in Minnesota?
Access BNP II (K262597) by Beckman Coulter, Inc. was cleared on 2026-10-20 after 85 days of review.
How does Access BNP II (K262597): 510(k) cleared for Beckman Coulter, Inc. compare to other Minnesota FDAPulse records?
Its amount of 85 is below the median (25th percentile); smaller records often move faster and face less competition. It is 15 days old, still within a typical 45-day follow-up window. Its Predicate Speed & CAPA Advisory Opportunity Score of 36/100 is modest; treat it as background rather than a priority.
Access BNP II (K262597) vs. top 3 peers
| Organization | Location | Record date |
|---|---|---|
| Access BNP II (K262597) | MN | 2026-10-20 |
| BD Vacutainer® Serum Blood Collection Tubes; BD Vacutainer® Rapid Serum Tubes (RST) (K252344) | NJ | 2026-10-16 |
| EASYMAX Voice Blood Glucose Monitoring System (K261293) | TW | 2026-10-23 |
| Sol-Guard Safety Pull Button Collection Set; Sol-Guard XtraThin Safety Pull-Button Blood Collection Set (K260857) | IL | 2026-10-21 |
Compare Access BNP II (K262597) vs Access NT-proBNP (K262109) →
Related records
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- Sol-Guard Safety Pull Button Collection Set; Sol-Guard XtraThin Safety Pull-Button Blood Collection Set (K260857): 510(k) cleared for Sol-Millennium Medical, Inc.
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- Access NT-proBNP (K262109): 510(k) cleared for Beckman Coulter, Inc.
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