CraniUS Plate (K262874): 510(k) cleared for CraniUS, LLC
CraniUS Plate (K262874): 510(k) cleared for CraniUS, LLC (Maryland): 510(k) cleared for CraniUS, LLC. Its amount of 28 is below the median of 138 (6th percentile). Dated 55 days ago, it serves as a historical benchmark. Score 35/100. 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: 28 · 6th percentile of 414 FDAPulse records · 0.2x the median
Free preview: all 14 published fields of this record are shown below. Locked: 4 related MD FDAPulse records and the 5-column CSV export.
| Field | Value |
|---|---|
| Record | 510(k) clearance |
| 510(k) number | K262874 |
| Device | CraniUS Plate |
| Applicant | CraniUS, LLC |
| Specialty / panel | Neurology |
| Product code | GWO |
| Device class | 2 |
| Clearance type | Special |
| Decision | Substantially Equivalent |
| Received | 2026-08-14 |
| Decision date | 2026-09-11 |
| Review time (days) | 28 |
| Third-party review | No |
| Applicant location | Baltimore, MD, US |
| amount percentile | 6th of 414 (median 138, 0.2x median) |
| Peer records CSV (5 MD records) | 🔒 Click to unlock → |
| CRM-ready export with official source URLs | 🔒 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: 2026-09-11
- Data refreshed: 2026-11-04
- Refunds on request within 14 days
Top FDAPulse records (MD first): Oncomine Dx Express Test (K260827) · BD BBL Mueller Hinton II Broth (Cation-Adjusted); BD Difco M · Class II recall Z-0139-2027 · Class II recall Z-0140-2027 · SmartIPL_NI System (K241973) · Browse all by state and category →
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: CraniUS Plate (K262874): 510(k) cleared for CraniUS, LLC and 5 Maryland peers
- Maryland FDAPulse records like this one: 5
- CraniUS Plate (K262874): 510(k) cleared for CraniUS, LLC's amount: 6th percentile of 414 records
- Timing: Low: older than 30 days
- Estimated pipeline if you contact every Maryland peer: $1,000 (peers × rate × deal size; an estimate from your assumptions, not a forecast)
35 / 100 Predicate Speed & CAPA Advisory Opportunity Score
- Fast 28-day review: this device is a strong predicate for similar products.
- Special 510(k): a modification of an existing device.
What is the FDAPulse record for CraniUS Plate (K262874): 510(k) cleared for CraniUS, LLC in Maryland?
CraniUS Plate (K262874) by CraniUS, LLC was cleared on 2026-09-11 after 28 days of review.
How does CraniUS Plate (K262874): 510(k) cleared for CraniUS, LLC compare to other Maryland FDAPulse records?
Its amount of 28 is below the median (6th percentile); smaller records often move faster and face less competition. It is 55 days old; check the official source for later updates before acting. Its Predicate Speed & CAPA Advisory Opportunity Score of 35/100 is modest; treat it as background rather than a priority.
CraniUS Plate (K262874) vs. top 3 peers
| Organization | Location | Record date |
|---|---|---|
| CraniUS Plate (K262874) | MD | 2026-09-11 |
| 7D Surgical System (10-0001) (K260403) | CA | 2026-10-19 |
| cCeLL - In vivo (K260315) | KR | 2026-10-16 |
| Neurora (K260064) | NH | 2026-10-02 |
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