Drainage Catheter (K254179): 510(k) cleared for Canyon Medical, Inc.
Drainage Catheter (K254179): 510(k) cleared for Canyon Medical, Inc.: 510(k) cleared for Canyon Medical, Inc. Its amount of 269 is top-decile (93rd percentile of 414 records). Dated 48 days ago, it serves as a historical benchmark. Score 55/100. 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: 269 · 93th percentile of 414 FDAPulse records · 1.9x the median
Free preview: all 14 published fields of this record are shown below. Locked: 75 related CN FDAPulse records and the 5-column CSV export.
| Field | Value |
|---|---|
| Record | 510(k) clearance |
| 510(k) number | K254179 |
| Device | Drainage Catheter |
| Applicant | Canyon Medical, Inc. |
| Specialty / panel | Gastroenterology, Urology |
| Product code | FGE |
| Device class | 2 |
| Clearance type | Traditional |
| Decision | Substantially Equivalent |
| Received | 2025-12-23 |
| Decision date | 2026-09-18 |
| Review time (days) | 269 |
| Third-party review | No |
| Applicant location | Nanjing, CN |
| amount percentile | 93th of 414 (median 138, 1.9x median) |
| Peer records CSV (76 CN 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: 2026-09-18
- 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: Drainage Catheter (K254179): 510(k) cleared for Canyon Medical, Inc. and 76 CN peers
- CN FDAPulse records like this one: 76
- Drainage Catheter (K254179): 510(k) cleared for Canyon Medical, Inc.'s amount: 93rd percentile of 414 records
- Timing: Low: older than 30 days
- Estimated pipeline if you contact every CN peer: $15,200 (peers × rate × deal size; an estimate from your assumptions, not a forecast)
55 / 100 Predicate Speed & CAPA Advisory Opportunity Score
- A long 269-day review suggests additional-information requests: a firm likely to value regulatory help next time.
What is the FDAPulse record for Drainage Catheter (K254179): 510(k) cleared for Canyon Medical, Inc.?
Drainage Catheter (K254179) by Canyon Medical, Inc. was cleared on 2026-09-18 after 269 days of review.
How does Drainage Catheter (K254179): 510(k) cleared for Canyon Medical, Inc. compare to other FDAPulse records?
This is a top-decile record: its amount of 269 is 1.9x the median of 138 across 414 records. It is 48 days old; check the official source for later updates before acting.
Drainage Catheter (K254179) vs. top 2 peers
| Organization | Location | Record date |
|---|---|---|
| Drainage Catheter (K254179) | CN | 2026-09-18 |
| Disposable Ureteral Access Sheath (K260512) | CN | 2026-09-21 |
| Single Use Ureteral Access Sheath (K260410) | CN | 2026-09-11 |
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Recent FDA 510(k) clearances FDA 510(k) clearances and recalls: Gastroenterology & Urology devices
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