OpenFlo Urinary Catheter (K261141): 510(k) cleared for Urolution Medical, Inc.
OpenFlo Urinary Catheter (K261141): 510(k) cleared for Urolution Medical, Inc. (Minnesota): 510(k) cleared for Urolution Medical, Inc. Its amount of 182 is above the median of 138 (64th percentile). Dated 29 days ago, it is in the active follow-up window. Score 48/100. 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: 182 · 64th percentile of 414 FDAPulse records · 1.3x the median
Free preview: all 14 published fields of this record are shown below. Locked: 11 related MN FDAPulse records and the 5-column CSV export.
| Field | Value |
|---|---|
| Record | 510(k) clearance |
| 510(k) number | K261141 |
| Device | OpenFlo Urinary Catheter |
| Applicant | Urolution Medical, Inc. |
| Specialty / panel | Gastroenterology, Urology |
| Product code | EZL |
| Device class | 2 |
| Clearance type | Traditional |
| Decision | Substantially Equivalent |
| Received | 2026-04-07 |
| Decision date | 2026-10-06 |
| Review time (days) | 182 |
| Third-party review | No |
| Applicant location | Maple Grove, MN, US |
| amount percentile | 64th of 414 (median 138, 1.3x 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: 2026-10-06
- Data refreshed: 2026-11-03
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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: OpenFlo Urinary Catheter (K261141): 510(k) cleared for Urolution Medical, Inc. and 12 Minnesota peers
- Minnesota FDAPulse records like this one: 12
- OpenFlo Urinary Catheter (K261141): 510(k) cleared for Urolution Medical, Inc.'s amount: 64th percentile of 414 records
- Timing: Medium: dated in the last 30 days
- Estimated pipeline if you contact every Minnesota peer: $2,400 (peers × rate × deal size; an estimate from your assumptions, not a forecast)
48 / 100 Predicate Speed & CAPA Advisory Opportunity Score
- 182-day review, longer than typical.
- Posted 29 days ago.
What is the FDAPulse record for OpenFlo Urinary Catheter (K261141): 510(k) cleared for Urolution Medical, Inc. in Minnesota?
OpenFlo Urinary Catheter (K261141) by Urolution Medical, Inc. was cleared on 2026-10-06 after 182 days of review.
How does OpenFlo Urinary Catheter (K261141): 510(k) cleared for Urolution Medical, Inc. compare to other Minnesota FDAPulse records?
Its amount of 182 sits in the upper half (64th percentile) of 414 records; the median is 138. It is 29 days old, still within a typical 45-day follow-up window.
OpenFlo Urinary Catheter (K261141) vs. top 3 peers
| Organization | Location | Record date |
|---|---|---|
| OpenFlo Urinary Catheter (K261141) | MN | 2026-10-06 |
| CapsoView (CVV); CapsoCloud (CLD) (K254230) | CA | 2026-09-25 |
| Drainage Catheter (K254179) | CN | 2026-09-18 |
| colonic FTRD Set (200.70); diagnostic FTRD Set (200.76); gastroduodenal FTRD Set (200.72) (K253481) | DE | 2026-09-14 |
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