DRIM-Nail System (K260115): 510(k) cleared for 41Medical AG
DRIM-Nail System (K260115): 510(k) cleared for 41Medical AG: 510(k) cleared for 41Medical AG. Its amount of 240 is above the median of 138 (77th percentile). Dated 54 days ago, it serves as a historical benchmark. Score 42/100. 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: 240 · 77th percentile of 414 FDAPulse records · 1.7x the median
Free preview: all 12 published fields of this record are shown below. Locked: 6 related CH FDAPulse records and the 5-column CSV export.
| Field | Value |
|---|---|
| Record | 510(k) clearance |
| 510(k) number | K260115 |
| Device | DRIM-Nail System |
| Applicant | 41Medical AG |
| Specialty / panel | Other |
| Clearance type | Traditional |
| Decision | Substantially Equivalent |
| Received | 2026-01-14 |
| Decision date | 2026-09-11 |
| Review time (days) | 240 |
| Third-party review | No |
| Applicant location | Bettlach, CH |
| amount percentile | 77th of 414 (median 138, 1.7x median) |
| Peer records CSV (7 CH 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: 2026-11-03
- Refunds on request within 14 days
Top FDAPulse records (CH first): ErgoSteel (ES0001/696) (K253762) · M-Vizion Femoral Revision System Extension (K260173) · CAS-One IR (K261225) · OTOPLAN (K262080) · GMK Extension (K262057) · 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: DRIM-Nail System (K260115): 510(k) cleared for 41Medical AG and 7 CH peers
- CH FDAPulse records like this one: 7
- DRIM-Nail System (K260115): 510(k) cleared for 41Medical AG's amount: 77th percentile of 414 records
- Timing: Low: older than 30 days
- Estimated pipeline if you contact every CH peer: $1,400 (peers × rate × deal size; an estimate from your assumptions, not a forecast)
42 / 100 Predicate Speed & CAPA Advisory Opportunity Score
- 240-day review, longer than typical.
What is the FDAPulse record for DRIM-Nail System (K260115): 510(k) cleared for 41Medical AG?
DRIM-Nail System (K260115) by 41Medical AG was cleared on 2026-09-11 after 240 days of review.
How does DRIM-Nail System (K260115): 510(k) cleared for 41Medical AG compare to other FDAPulse records?
Its amount of 240 sits in the upper half (77th percentile) of 414 records; the median is 138. It is 54 days old; check the official source for later updates before acting.
DRIM-Nail System (K260115) vs. top 3 peers
| Organization | Location | Record date |
|---|---|---|
| DRIM-Nail System (K260115) | CH | 2026-09-11 |
| Needle Stimulator (SDZ-IIB, SDZ-IIC, SDZ-III, SDZ-V) (K260230) | CN | 2026-10-22 |
| STA® - Liquid Anti-Xa (K260214) | NJ | 2026-09-24 |
| BD OneFlow LST; BD OneFlow B-CLPD T1; BD FACSLyric Flow Cytometer, 8-color [4-2-2], 10-color [4-3-3], 12-color (4-3-5) (K260215) | CA | 2026-10-20 |
Compare DRIM-Nail System (K260115) vs ErgoSteel (ES0001/696) (K253762) →
Related records
- Needle Stimulator (SDZ-IIB, SDZ-IIC, SDZ-III, SDZ-V) (K260230): 510(k) cleared for Suzhou Medical Appliance Factory
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- BD OneFlow LST; BD OneFlow B-CLPD T1; BD FACSLyric Flow Cytometer, 8-color [4-2-2], 10-color [4-3-3], 12-color (4-3-5) (K260215): 510(k) cleared for Bd Biosciences
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