LuxDesign (K260421): 510(k) cleared for LuxCreo, Inc.
LuxDesign (K260421): 510(k) cleared for LuxCreo, Inc. (Illinois): 510(k) cleared for LuxCreo, Inc. Its amount of 256 is above the median of 138 (81st percentile). Dated 13 days ago, it is in the active follow-up window. Score 67/100. 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: 256 · 81th percentile of 414 FDAPulse records · 1.9x the median
Free preview: all 14 published fields of this record are shown below. Locked: 56 related IL FDAPulse records and the 5-column CSV export.
| Field | Value |
|---|---|
| Record | 510(k) clearance |
| 510(k) number | K260421 |
| Device | LuxDesign |
| Applicant | LuxCreo, Inc. |
| Specialty / panel | Dental |
| Product code | PNN |
| Device class | 2 |
| Clearance type | Traditional |
| Decision | Substantially Equivalent |
| Received | 2026-02-09 |
| Decision date | 2026-10-23 |
| Review time (days) | 256 |
| Third-party review | No |
| Applicant location | Chicago, IL, US |
| amount percentile | 81th of 414 (median 138, 1.9x median) |
| Peer records CSV (57 IL 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: 2026-10-23
- 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: LuxDesign (K260421): 510(k) cleared for LuxCreo, Inc. and 57 Illinois peers
- Illinois FDAPulse records like this one: 57
- LuxDesign (K260421): 510(k) cleared for LuxCreo, Inc.'s amount: 81st percentile of 414 records
- Timing: Medium: dated in the last 30 days
- Estimated pipeline if you contact every Illinois peer: $11,400 (peers × rate × deal size; an estimate from your assumptions, not a forecast)
67 / 100 Predicate Speed & CAPA Advisory Opportunity Score
- A long 256-day review suggests additional-information requests: a firm likely to value regulatory help next time.
- Posted 13 days ago.
What is the FDAPulse record for LuxDesign (K260421): 510(k) cleared for LuxCreo, Inc. in Illinois?
LuxDesign (K260421) by LuxCreo, Inc. was cleared on 2026-10-23 after 256 days of review.
How does LuxDesign (K260421): 510(k) cleared for LuxCreo, Inc. compare to other Illinois FDAPulse records?
Its amount of 256 sits in the upper half (81th percentile) of 414 records; the median is 138. It is fresh: dated 13 days ago, inside the window where early outreach matters most.
LuxDesign (K260421) vs. top 3 peers
| Organization | Location | Record date |
|---|---|---|
| LuxDesign (K260421) | IL | 2026-10-23 |
| Mobile Dental Solution (Model | CN | 2026-10-23 |
| Forza (K260136) | CA | 2026-10-06 |
| Wishbone HAE (K260096) | BE | 2026-10-09 |
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