Extroducer Infusion Catheter System (K254051): 510(k) cleared for SmartWise Sweden AB
Extroducer Infusion Catheter System (K254051): 510(k) cleared for SmartWise Sweden AB: 510(k) cleared for SmartWise Sweden AB. Its amount of 268 is top-decile (90th percentile of 414 records). Dated 54 days ago, it serves as a historical benchmark. Score 55/100. 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: 268 · 90th percentile of 414 FDAPulse records · 1.9x the median
Free preview: all 14 published fields of this record are shown below. Locked: 1 related SE FDAPulse records and the 5-column CSV export.
| Field | Value |
|---|---|
| Record | 510(k) clearance |
| 510(k) number | K254051 |
| Device | Extroducer Infusion Catheter System |
| Applicant | SmartWise Sweden AB |
| Specialty / panel | Cardiovascular |
| Product code | KRA |
| Device class | 2 |
| Clearance type | Traditional |
| Decision | Substantially Equivalent |
| Received | 2025-12-17 |
| Decision date | 2026-09-11 |
| Review time (days) | 268 |
| Third-party review | No |
| Applicant location | Tullinge, SE |
| amount percentile | 90th 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: 2026-09-11
- Data refreshed: 2026-11-03
- 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: Tue, 03 Nov 2026 18:05:14 GMT
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Peer benchmark and outreach value: Extroducer Infusion Catheter System (K254051): 510(k) cleared for SmartWise Sweden AB and 2 SE peers
- SE FDAPulse records like this one: 2
- Extroducer Infusion Catheter System (K254051): 510(k) cleared for SmartWise Sweden AB's amount: 90th percentile of 414 records
- Timing: Low: older than 30 days
- Estimated pipeline if you contact every SE peer: $400 (peers × rate × deal size; an estimate from your assumptions, not a forecast)
55 / 100 Predicate Speed & CAPA Advisory Opportunity Score
- A long 268-day review suggests additional-information requests: a firm likely to value regulatory help next time.
What is the FDAPulse record for Extroducer Infusion Catheter System (K254051): 510(k) cleared for SmartWise Sweden AB?
Extroducer Infusion Catheter System (K254051) by SmartWise Sweden AB was cleared on 2026-09-11 after 268 days of review.
How does Extroducer Infusion Catheter System (K254051): 510(k) cleared for SmartWise Sweden AB compare to other FDAPulse records?
This is a top-decile record: its amount of 268 is 1.9x the median of 138 across 414 records. It is 54 days old; check the official source for later updates before acting.
Extroducer Infusion Catheter System (K254051) vs. top 3 peers
| Organization | Location | Record date |
|---|---|---|
| Extroducer Infusion Catheter System (K254051) | SE | 2026-09-11 |
| Hemotag Analysis Software (HAS) (K252736) | FL | 2026-10-21 |
| TriSalus TriNav Advance Infusion System (K253509) | CO | 2026-09-21 |
| Small Diameter Core Wire (CMAN-000-00); Small Diameter Core Wire (CMAN-000-14) (K260168) | TX | 2026-10-16 |
Compare Extroducer Infusion Catheter System (K254051) vs Tempus ECG-MR (K254297) →
Compare Extroducer Infusion Catheter System (K254051) vs eClinics (K260075) →
Related records
- Hemotag Analysis Software (HAS) (K252736): 510(k) cleared for Aventusoft, LLC
- TriSalus TriNav Advance Infusion System (K253509): 510(k) cleared for Trisalus Life Sciences
- Small Diameter Core Wire (CMAN-000-00); Small Diameter Core Wire (CMAN-000-14) (K260168): 510(k) cleared for Skycade Med Corporation
- eClinics (K260075): 510(k) cleared for Ceiba Healthcare US, Inc.
- MyoVista wavECG (DG-200-B15-003) (K260005): 510(k) cleared for HeartSciences, Inc.
- OAB Delivery Catheter (K253422): 510(k) cleared for Cognition Medical Corp.
- ECG Analysis Software (AiTiALVSD) (K254302): 510(k) cleared for Medical AI Co., Ltd.
- QCA 10 Electrocardiograph (QCARD-10); QCA 10W Electrocardiograph (QCARD-10W) (K260250): 510(k) cleared for QT Medical, Inc.
- DistaSense(TM) (v1) (K254058): 510(k) cleared for Life Detection Technologies
- S-Patch CardioAI (K254255): 510(k) cleared for Wellysis Corp.
- Tempus ECG-MR (K254297): 510(k) cleared for Tempus AI, Inc.
- Echo-2 (K254240): 510(k) cleared for Neko Health AB
Recent FDA 510(k) clearances FDA 510(k) clearances and recalls: Cardiovascular devices
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