Small Diameter Core Wire (CMAN-000-00); Small Diameter Core Wire (CMAN-000-14) (K260168): 510(k) cleared for Skycade Med Corporation
Small Diameter Core Wire (CMAN-000-00); Small Diameter Core Wire (CMAN-000-14) (K260168): 510(k) cleared for Skycade Med Corporation (Texas): 510(k) cleared for Skycade Med Corporation. Its amount of 269 is top-decile (93rd percentile of 414 records). Dated 20 days ago, it is in the active follow-up window. 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: 269 · 93th percentile of 414 FDAPulse records · 1.9x the median
Free preview: all 14 published fields of this record are shown below. Locked: 11 related TX FDAPulse records and the 5-column CSV export.
| Field | Value |
|---|---|
| Record | 510(k) clearance |
| 510(k) number | K260168 |
| Device | Small Diameter Core Wire (CMAN-000-00); Small Diameter Core Wire (CMAN-000-14) |
| Applicant | Skycade Med Corporation |
| Specialty / panel | Cardiovascular |
| Product code | DQX |
| Device class | 2 |
| Clearance type | Traditional |
| Decision | Substantially Equivalent |
| Received | 2026-01-20 |
| Decision date | 2026-10-16 |
| Review time (days) | 269 |
| Third-party review | No |
| Applicant location | Dallas, TX, US |
| amount percentile | 93th of 414 (median 138, 1.9x median) |
| Peer records CSV (12 TX records) | 🔒 Click to unlock → |
| CRM-ready export with official source URLs | 🔒 Click to unlock → |
Watch Small Diameter Core Wire (CMAN-000-00); Small Diameter Core Wire (CMAN-000-14) (K260168): 510(k) cleared for Skycade Med Corporation
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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: 2026-10-16
- Data refreshed: 2026-11-04
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Top FDAPulse records (TX first): MyoVista wavECG (DG-200-B15-003) (K260005) · Kinetic Software Library (K260640) · SmartRead(TM) Medical Device Identifier (4100) (DEN260007) · DASH Flu A/B Test (K261347) · Ntegrate Threaded Nail System (K261961) · 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: Small Diameter Core Wire (CMAN-000-00); Small Diameter Core Wire (CMAN-000-14) (K260168): 510(k) cleared for Skycade Med Corporation and 12 Texas peers
- Texas FDAPulse records like this one: 12
- Small Diameter Core Wire (CMAN-000-00); Small Diameter Core Wire (CMAN-000-14) (K260168): 510(k) cleared for Skycade Med Corporation's amount: 93rd percentile of 414 records
- Timing: Medium: dated in the last 30 days
- Estimated pipeline if you contact every Texas peer: $2,400 (peers × rate × deal size; an estimate from your assumptions, not a forecast)
61 / 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.
- Posted 20 days ago.
What is the FDAPulse record for Small Diameter Core Wire (CMAN-000-00); Small Diameter Core Wire (CMAN-000-14) (K260168): 510(k) cleared for Skycade Med Corporation in Texas?
Small Diameter Core Wire (CMAN-000-00); Small Diameter Core Wire (CMAN-000-14) (K260168) by Skycade Med Corporation was cleared on 2026-10-16 after 269 days of review.
How does Small Diameter Core Wire (CMAN-000-00); Small Diameter Core Wire (CMAN-000-14) (K260168): 510(k) cleared for Skycade Med Corporation compare to other Texas FDAPulse records?
This is a top-decile record: its amount of 269 is 1.9x the median of 138 across 414 records. It is 20 days old, still within a typical 45-day follow-up window.
Small Diameter Core Wire (CMAN-000-00); Small Diameter Core Wire (CMAN-000-14) (K260168) vs. top 3 peers
| Organization | Location | Record date |
|---|---|---|
| Small Diameter Core Wire (CMAN-000-00); Small Diameter Core Wire (CMAN-000-14) (K260168) | TX | 2026-10-16 |
| TriSalus TriNav Advance Infusion System (K253509) | CO | 2026-09-21 |
| Hemotag Analysis Software (HAS) (K252736) | FL | 2026-10-21 |
| eClinics (K260075) | NY | 2026-10-07 |
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Recent FDA 510(k) clearances FDA 510(k) clearances and recalls: Cardiovascular devices
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