danumed StomaMeter (K262038): 510(k) cleared for Danumed Medizintechnik GmbH
danumed StomaMeter (K262038): 510(k) cleared for Danumed Medizintechnik GmbH (Delaware): 510(k) cleared for Danumed Medizintechnik GmbH. Its amount of 105 is below the median of 138 (38th percentile). Dated 36 days ago, it serves as a historical benchmark. Score 36/100. 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: 105 · 38th percentile of 414 FDAPulse records · 0.8x 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 | K262038 |
| Device | danumed StomaMeter |
| Applicant | Danumed Medizintechnik GmbH |
| Specialty / panel | Gastroenterology, Urology |
| Product code | KNT |
| Device class | 2 |
| Clearance type | Traditional |
| Decision | Substantially Equivalent |
| Received | 2026-06-17 |
| Decision date | 2026-09-30 |
| Review time (days) | 105 |
| Third-party review | No |
| Applicant location | Regensburg, DE |
| amount percentile | 38th of 414 (median 138, 0.8x 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: 2026-09-30
- 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: danumed StomaMeter (K262038): 510(k) cleared for Danumed Medizintechnik GmbH and 25 Delaware peers
- Delaware FDAPulse records like this one: 25
- danumed StomaMeter (K262038): 510(k) cleared for Danumed Medizintechnik GmbH's amount: 38th 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)
36 / 100 Predicate Speed & CAPA Advisory Opportunity Score
- Fast 105-day review: this device is a strong predicate for similar products.
- Posted 36 days ago.
What is the FDAPulse record for danumed StomaMeter (K262038): 510(k) cleared for Danumed Medizintechnik GmbH in Delaware?
danumed StomaMeter (K262038) by Danumed Medizintechnik GmbH was cleared on 2026-09-30 after 105 days of review.
How does danumed StomaMeter (K262038): 510(k) cleared for Danumed Medizintechnik GmbH compare to other Delaware FDAPulse records?
Its amount of 105 is below the median (38th percentile); smaller records often move faster and face less competition. It is 36 days old, still within a typical 45-day follow-up window. Its Predicate Speed & CAPA Advisory Opportunity Score of 36/100 is modest; treat it as background rather than a priority.
danumed StomaMeter (K262038) vs. top 2 peers
| Organization | Location | Record date |
|---|---|---|
| danumed StomaMeter (K262038) | DE | 2026-09-30 |
| colonic FTRD Set (200.70); diagnostic FTRD Set (200.76); gastroduodenal FTRD Set (200.72) (K253481) | DE | 2026-09-14 |
| stentFIX System Set (100.50n) (K260487) | DE | 2026-10-02 |
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