EnSite X EP System (K261729): 510(k) cleared for Abbott Medical
EnSite X EP System (K261729): 510(k) cleared for Abbott Medical (Minnesota): 510(k) cleared for Abbott Medical. Its amount of 114 is below the median of 138 (41st percentile). Dated 48 days ago, it serves as a historical benchmark. Score 30/100. 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: 114 · 41th percentile of 414 FDAPulse records · 0.8x 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 | K261729 |
| Device | EnSite X EP System |
| Applicant | Abbott Medical |
| Specialty / panel | Cardiovascular |
| Product code | DQK |
| Device class | 2 |
| Clearance type | Traditional |
| Decision | Substantially Equivalent |
| Received | 2026-05-26 |
| Decision date | 2026-09-17 |
| Review time (days) | 114 |
| Third-party review | No |
| Applicant location | St. Paul, MN, US |
| amount percentile | 41th of 414 (median 138, 0.8x 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: 2026-09-17
- 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: EnSite X EP System (K261729): 510(k) cleared for Abbott Medical and 12 Minnesota peers
- Minnesota FDAPulse records like this one: 12
- EnSite X EP System (K261729): 510(k) cleared for Abbott Medical's amount: 41st 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)
30 / 100 Predicate Speed & CAPA Advisory Opportunity Score
- Fast 114-day review: this device is a strong predicate for similar products.
What is the FDAPulse record for EnSite X EP System (K261729): 510(k) cleared for Abbott Medical in Minnesota?
EnSite X EP System (K261729) by Abbott Medical was cleared on 2026-09-17 after 114 days of review.
How does EnSite X EP System (K261729): 510(k) cleared for Abbott Medical compare to other Minnesota FDAPulse records?
Its amount of 114 is below the median (41th percentile); smaller records often move faster and face less competition. It is 48 days old; check the official source for later updates before acting. Its Predicate Speed & CAPA Advisory Opportunity Score of 30/100 is modest; treat it as background rather than a priority.
EnSite X EP System (K261729) vs. top 3 peers
| Organization | Location | Record date |
|---|---|---|
| EnSite X EP System (K261729) | MN | 2026-09-17 |
| Hemotag Analysis Software (HAS) (K252736) | FL | 2026-10-21 |
| TriSalus TriNav Advance Infusion System (K253509) | CO | 2026-09-21 |
| Small Diameter Core Wire (CMAN-000-00); Small Diameter Core Wire (CMAN-000-14) (K260168) | TX | 2026-10-16 |
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