EzSensor HD (K261663): 510(k) cleared for Qpix Solutions, Inc.
EzSensor HD (K261663): 510(k) cleared for Qpix Solutions, Inc. (North Carolina): 510(k) cleared for Qpix Solutions, Inc. Its amount of 133 is below the median of 138 (49th percentile). Dated 35 days ago, it serves as a historical benchmark. 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: 133 · 49th percentile of 414 FDAPulse records · 1.0x the median
Free preview: all 14 published fields of this record are shown below. Locked: 8 related NC FDAPulse records and the 5-column CSV export.
| Field | Value |
|---|---|
| Record | 510(k) clearance |
| 510(k) number | K261663 |
| Device | EzSensor HD |
| Applicant | Qpix Solutions, Inc. |
| Specialty / panel | Dental |
| Product code | MUH |
| Device class | 2 |
| Clearance type | Traditional |
| Decision | Substantially Equivalent |
| Received | 2026-05-20 |
| Decision date | 2026-09-30 |
| Review time (days) | 133 |
| Third-party review | No |
| Applicant location | Morrisville, NC, US |
| amount percentile | 49th of 414 (median 138, 1.0x 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: 2026-09-30
- 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: EzSensor HD (K261663): 510(k) cleared for Qpix Solutions, Inc. and 9 North Carolina peers
- North Carolina FDAPulse records like this one: 9
- EzSensor HD (K261663): 510(k) cleared for Qpix Solutions, Inc.'s amount: 49th percentile of 414 records
- Timing: Low: older than 30 days
- Estimated pipeline if you contact every North Carolina peer: $1,800 (peers × rate × deal size; an estimate from your assumptions, not a forecast)
36 / 100 Predicate Speed & CAPA Advisory Opportunity Score
- Fast 133-day review: this device is a strong predicate for similar products.
- Posted 35 days ago.
What is the FDAPulse record for EzSensor HD (K261663): 510(k) cleared for Qpix Solutions, Inc. in North Carolina?
EzSensor HD (K261663) by Qpix Solutions, Inc. was cleared on 2026-09-30 after 133 days of review.
How does EzSensor HD (K261663): 510(k) cleared for Qpix Solutions, Inc. compare to other North Carolina FDAPulse records?
Its amount of 133 is below the median (49th percentile); smaller records often move faster and face less competition. It is 35 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.
EzSensor HD (K261663) vs. top 3 peers
| Organization | Location | Record date |
|---|---|---|
| EzSensor HD (K261663) | NC | 2026-09-30 |
| LuxDesign (K260421) | IL | 2026-10-23 |
| Mobile Dental Solution (Model | CN | 2026-10-23 |
| Forza (K260136) | CA | 2026-10-06 |
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