ZBPro Diagnostic (Version 2.0) (K261580): 510(k) cleared for Zbeats, Inc.
ZBPro Diagnostic (Version 2.0) (K261580): 510(k) cleared for Zbeats, Inc. (New York): 510(k) cleared for Zbeats, Inc. Its amount of 121 is below the median of 138 (45th percentile). Dated 54 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: 121 · 45th percentile of 414 FDAPulse records · 0.9x the median
Free preview: all 14 published fields of this record are shown below. Locked: 6 related NY FDAPulse records and the 5-column CSV export.
| Field | Value |
|---|---|
| Record | 510(k) clearance |
| 510(k) number | K261580 |
| Device | ZBPro Diagnostic (Version 2.0) |
| Applicant | Zbeats, Inc. |
| Specialty / panel | Cardiovascular |
| Product code | MLO |
| Device class | 2 |
| Clearance type | Traditional |
| Decision | Substantially Equivalent |
| Received | 2026-05-13 |
| Decision date | 2026-09-11 |
| Review time (days) | 121 |
| Third-party review | No |
| Applicant location | Stony Brook, NY, US |
| amount percentile | 45th of 414 (median 138, 0.9x 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: 2026-09-11
- Data refreshed: 2026-11-03
- Refunds on request within 14 days
Top FDAPulse records (NY first): eClinics (K260075) · MICSI-PET (K261305) · Bausch + Lomb Multifocal for Astigmatism (kalifilcon A) One- · Class II recall Z-0204-2027 · Class II recall Z-0107-2027 · Browse all by state and category →
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: ZBPro Diagnostic (Version 2.0) (K261580): 510(k) cleared for Zbeats, Inc. and 7 New York peers
- New York FDAPulse records like this one: 7
- ZBPro Diagnostic (Version 2.0) (K261580): 510(k) cleared for Zbeats, Inc.'s amount: 45th percentile of 414 records
- Timing: Low: older than 30 days
- Estimated pipeline if you contact every New York peer: $1,400 (peers × rate × deal size; an estimate from your assumptions, not a forecast)
30 / 100 Predicate Speed & CAPA Advisory Opportunity Score
- Fast 121-day review: this device is a strong predicate for similar products.
What is the FDAPulse record for ZBPro Diagnostic (Version 2.0) (K261580): 510(k) cleared for Zbeats, Inc. in New York?
ZBPro Diagnostic (Version 2.0) (K261580) by Zbeats, Inc. was cleared on 2026-09-11 after 121 days of review.
How does ZBPro Diagnostic (Version 2.0) (K261580): 510(k) cleared for Zbeats, Inc. compare to other New York FDAPulse records?
Its amount of 121 is below the median (45th percentile); smaller records often move faster and face less competition. It is 54 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.
ZBPro Diagnostic (Version 2.0) (K261580) vs. top 3 peers
| Organization | Location | Record date |
|---|---|---|
| ZBPro Diagnostic (Version 2.0) (K261580) | NY | 2026-09-11 |
| 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 |
Related records
- Hemotag Analysis Software (HAS) (K252736): 510(k) cleared for Aventusoft, LLC
- TriSalus TriNav Advance Infusion System (K253509): 510(k) cleared for Trisalus Life Sciences
- Small Diameter Core Wire (CMAN-000-00); Small Diameter Core Wire (CMAN-000-14) (K260168): 510(k) cleared for Skycade Med Corporation
- eClinics (K260075): 510(k) cleared for Ceiba Healthcare US, Inc.
- MyoVista wavECG (DG-200-B15-003) (K260005): 510(k) cleared for HeartSciences, Inc.
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- DistaSense(TM) (v1) (K254058): 510(k) cleared for Life Detection Technologies
- S-Patch CardioAI (K254255): 510(k) cleared for Wellysis Corp.
- Tempus ECG-MR (K254297): 510(k) cleared for Tempus AI, Inc.
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