ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert, ISIS Xpress (K263010): 510(k) cleared for inomed Medizintechnik GmbH
ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert, ISIS Xpress (K263010): 510(k) cleared for inomed Medizintechnik GmbH (Delaware): 510(k) cleared for inomed Medizintechnik GmbH. Its amount of 27 is below the median of 138 (3rd percentile). Dated 42 days ago, it serves as a historical benchmark. Score 41/100. 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: 27 · 3th percentile of 414 FDAPulse records · 0.2x the median
Free preview: all 14 published fields of this record are shown below. Locked: 24 related DE FDAPulse records and the 5-column CSV export.
| Field | Value |
|---|---|
| Record | 510(k) clearance |
| 510(k) number | K263010 |
| Device | ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert, ISIS Xpress |
| Applicant | inomed Medizintechnik GmbH |
| Specialty / panel | Neurology |
| Product code | GWF |
| Device class | 2 |
| Clearance type | Special |
| Decision | Substantially Equivalent |
| Received | 2026-08-28 |
| Decision date | 2026-09-24 |
| Review time (days) | 27 |
| Third-party review | No |
| Applicant location | Emmendingen, DE |
| amount percentile | 3th of 414 (median 138, 0.2x median) |
| Peer records CSV (25 DE 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: 2026-09-24
- 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: ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert, ISIS Xpress (K263010): 510(k) cleared for inomed Medizintechnik GmbH and 25 Delaware peers
- Delaware FDAPulse records like this one: 25
- ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert, ISIS Xpress (K263010): 510(k) cleared for inomed Medizintechnik GmbH's amount: 3rd percentile of 414 records
- Timing: Low: older than 30 days
- Estimated pipeline if you contact every Delaware peer: $5,000 (peers × rate × deal size; an estimate from your assumptions, not a forecast)
41 / 100 Predicate Speed & CAPA Advisory Opportunity Score
- Fast 27-day review: this device is a strong predicate for similar products.
- Special 510(k): a modification of an existing device.
- Posted 42 days ago.
What is the FDAPulse record for ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert, ISIS Xpress (K263010): 510(k) cleared for inomed Medizintechnik GmbH in Delaware?
ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert, ISIS Xpress (K263010) by inomed Medizintechnik GmbH was cleared on 2026-09-24 after 27 days of review.
How does ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert, ISIS Xpress (K263010): 510(k) cleared for inomed Medizintechnik GmbH compare to other Delaware FDAPulse records?
Its amount of 27 is below the median (3th percentile); smaller records often move faster and face less competition. It is 42 days old, still within a typical 45-day follow-up window.
ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert, ISIS Xpress (K263010) vs. top 2 peers
| Organization | Location | Record date |
|---|---|---|
| ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert, ISIS Xpress (K263010) | DE | 2026-09-24 |
| KARL STORZ Flexible Video Neuro-Endoscope (K260581) | DE | 2026-10-14 |
| Tontarra Punches and Rongeurs (K260446) | DE | 2026-09-15 |
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