THERMEO® I MSI (K260031): 510(k) cleared for Pro3Dure Medical GmbH
THERMEO® I MSI (K260031): 510(k) cleared for Pro3Dure Medical GmbH (Delaware): 510(k) cleared for Pro3Dure Medical GmbH. Its amount of 266 is above the median of 138 (86th percentile). Dated 36 days ago, it serves as a historical benchmark. Score 61/100. 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: 266 · 86th percentile of 414 FDAPulse records · 1.9x 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 | K260031 |
| Device | THERMEO® I MSI |
| Applicant | Pro3Dure Medical GmbH |
| Specialty / panel | Other |
| Product code | MQC |
| Device class | U |
| Clearance type | Traditional |
| Decision | Substantially Equivalent |
| Received | 2026-01-06 |
| Decision date | 2026-09-29 |
| Review time (days) | 266 |
| Third-party review | No |
| Applicant location | Iserlohn, DE |
| amount percentile | 86th of 414 (median 138, 1.9x 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: 2026-09-29
- Data refreshed: 2026-11-04
- Refunds on request within 14 days
Top FDAPulse records (DE first): colonic FTRD Set (200.70); diagnostic FTRD Set (200.76); gas · Endox High Level Disinfectant (K254094) · Actolind® (06.3637. Actolind® Gel Plus) (K254168) · UNIDRIVE SIII System; HOPKINS Telescope 0º (26205AMA) Operat · KARL STORZ SUPRALOOP (K254303) · 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: THERMEO® I MSI (K260031): 510(k) cleared for Pro3Dure Medical GmbH and 25 Delaware peers
- Delaware FDAPulse records like this one: 25
- THERMEO® I MSI (K260031): 510(k) cleared for Pro3Dure Medical GmbH's amount: 86th 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)
61 / 100 Predicate Speed & CAPA Advisory Opportunity Score
- A long 266-day review suggests additional-information requests: a firm likely to value regulatory help next time.
- Posted 36 days ago.
What is the FDAPulse record for THERMEO® I MSI (K260031): 510(k) cleared for Pro3Dure Medical GmbH in Delaware?
THERMEO® I MSI (K260031) by Pro3Dure Medical GmbH was cleared on 2026-09-29 after 266 days of review.
How does THERMEO® I MSI (K260031): 510(k) cleared for Pro3Dure Medical GmbH compare to other Delaware FDAPulse records?
Its amount of 266 sits in the upper half (86th percentile) of 414 records; the median is 138. It is 36 days old, still within a typical 45-day follow-up window.
THERMEO® I MSI (K260031) vs. top 2 peers
| Organization | Location | Record date |
|---|---|---|
| THERMEO® I MSI (K260031) | DE | 2026-09-29 |
| Actolind® (06.3637. Actolind® Gel Plus) (K254168) | DE | 2026-09-22 |
| CLEARVISION Irrigation Sheath 0° (7241AS); CLEARVISION Irrigation Sheath 30° (7241BS); CLEARVISION Irrigation Sheath 45° (7241FS) (K254299) | DE | 2026-09-15 |
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