Access NT-proBNP (K262109): 510(k) cleared for Beckman Coulter, Inc.
Access NT-proBNP (K262109): 510(k) cleared for Beckman Coulter, Inc. (Minnesota): 510(k) cleared for Beckman Coulter, Inc. Its amount of 90 is below the median of 138 (31st percentile). Dated 44 days ago, it serves as a historical benchmark. Score 36/100. As of 2026-11-03, 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: 90 · 31th percentile of 414 FDAPulse records · 0.7x 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 | K262109 |
| Device | Access NT-proBNP |
| Applicant | Beckman Coulter, Inc. |
| Specialty / panel | Clinical Chemistry |
| Product code | NBC |
| Device class | 2 |
| Clearance type | Traditional |
| Decision | Substantially Equivalent |
| Received | 2026-06-23 |
| Decision date | 2026-09-21 |
| Review time (days) | 90 |
| Third-party review | No |
| Applicant location | Chaska, MN, US |
| amount percentile | 31th of 414 (median 138, 0.7x 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: 2026-09-21
- Data refreshed: 2026-11-03
- 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: Tue, 03 Nov 2026 18:05:14 GMT
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Peer benchmark and outreach value: Access NT-proBNP (K262109): 510(k) cleared for Beckman Coulter, Inc. and 12 Minnesota peers
- Minnesota FDAPulse records like this one: 12
- Access NT-proBNP (K262109): 510(k) cleared for Beckman Coulter, Inc.'s amount: 31st percentile of 414 records
- Timing: Low: older than 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 90-day review: this device is a strong predicate for similar products.
- Posted 44 days ago.
What is the FDAPulse record for Access NT-proBNP (K262109): 510(k) cleared for Beckman Coulter, Inc. in Minnesota?
Access NT-proBNP (K262109) by Beckman Coulter, Inc. was cleared on 2026-09-21 after 90 days of review.
How does Access NT-proBNP (K262109): 510(k) cleared for Beckman Coulter, Inc. compare to other Minnesota FDAPulse records?
Its amount of 90 is below the median (31th percentile); smaller records often move faster and face less competition. It is 44 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 NT-proBNP (K262109) vs. top 3 peers
| Organization | Location | Record date |
|---|---|---|
| Access NT-proBNP (K262109) | MN | 2026-09-21 |
| 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 NT-proBNP (K262109) vs Access BNP II (K262597) →
Related records
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- EASYMAX Voice Blood Glucose Monitoring System (K261293): 510(k) cleared for EPS Bio Technology Corp.
- 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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