Access MeMed BV (K261109): 510(k) cleared for Beckman Coulter, Inc.
Access MeMed BV (K261109): 510(k) cleared for Beckman Coulter, Inc. (Minnesota): 510(k) cleared for Beckman Coulter, Inc. Its amount of 199 is above the median of 138 (68th percentile). Dated 17 days ago, it is in the active follow-up window. Score 48/100. 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: 199 · 68th percentile of 414 FDAPulse records · 1.4x 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 | K261109 |
| Device | Access MeMed BV |
| Applicant | Beckman Coulter, Inc. |
| Specialty / panel | Microbiology |
| Product code | QPS |
| Device class | 2 |
| Clearance type | Traditional |
| Decision | Substantially Equivalent |
| Received | 2026-04-03 |
| Decision date | 2026-10-19 |
| Review time (days) | 199 |
| Third-party review | No |
| Applicant location | Chaska, MN, US |
| amount percentile | 68th of 414 (median 138, 1.4x median) |
| Peer records CSV (12 MN records) | 🔒 Click to unlock → |
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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: 2026-10-19
- 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 MeMed BV (K261109): 510(k) cleared for Beckman Coulter, Inc. and 12 Minnesota peers
- Minnesota FDAPulse records like this one: 12
- Access MeMed BV (K261109): 510(k) cleared for Beckman Coulter, Inc.'s amount: 68th 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)
48 / 100 Predicate Speed & CAPA Advisory Opportunity Score
- 199-day review, longer than typical.
- Posted 17 days ago.
What is the FDAPulse record for Access MeMed BV (K261109): 510(k) cleared for Beckman Coulter, Inc. in Minnesota?
Access MeMed BV (K261109) by Beckman Coulter, Inc. was cleared on 2026-10-19 after 199 days of review.
How does Access MeMed BV (K261109): 510(k) cleared for Beckman Coulter, Inc. compare to other Minnesota FDAPulse records?
Its amount of 199 sits in the upper half (68th percentile) of 414 records; the median is 138. It is 17 days old, still within a typical 45-day follow-up window.
Access MeMed BV (K261109) vs. top 3 peers
| Organization | Location | Record date |
|---|---|---|
| Access MeMed BV (K261109) | MN | 2026-10-19 |
| B·R·A·H·M·S MR-proADM KRYPTOR; B·R·A·H·M·S MR-proADM KRYPTOR CAL; B·R·A·H·M·S MR-proADM KRYPTOR QC (K260302) | DE | 2026-10-23 |
| Elecsys EBV EBNA IgG (K260221) | IN | 2026-10-02 |
| Elecsys EBV VCA IgG (K260232) | IN | 2026-10-02 |
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