X°Port Heart Preservation System (K261913): 510(k) cleared for Traferox Technologies, Inc.
X°Port Heart Preservation System (K261913): 510(k) cleared for Traferox Technologies, Inc. (California): 510(k) cleared for Traferox Technologies, Inc. Its amount of 100 is below the median of 138 (35th percentile). Dated 49 days ago, it serves as a historical benchmark. Score 30/100. 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: 100 · 35th percentile of 414 FDAPulse records · 0.7x the median
Free preview: all 14 published fields of this record are shown below. Locked: 75 related CA FDAPulse records and the 5-column CSV export.
| Field | Value |
|---|---|
| Record | 510(k) clearance |
| 510(k) number | K261913 |
| Device | X°Port Heart Preservation System |
| Applicant | Traferox Technologies, Inc. |
| Specialty / panel | Gastroenterology, Urology |
| Product code | MSB |
| Device class | 2 |
| Clearance type | Traditional |
| Decision | Substantially Equivalent |
| Received | 2026-06-08 |
| Decision date | 2026-09-16 |
| Review time (days) | 100 |
| Third-party review | No |
| Applicant location | Mississauga, CA |
| amount percentile | 35th of 414 (median 138, 0.7x 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: 2026-09-16
- Data refreshed: 2026-11-03
- Refunds on request within 14 days
Top FDAPulse records (CA first): Triever Duo Catheter (K253419) · Helo Return (K253717) · DistaSense(TM) (v1) (K254058) · BD OneFlow LST; BD OneFlow B-CLPD T1; BD FACSLyric Flow Cyto · CapsoView (CVV); CapsoCloud (CLD) (K254230) · Browse all by state and category →
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: X°Port Heart Preservation System (K261913): 510(k) cleared for Traferox Technologies, Inc. and 76 California peers
- California FDAPulse records like this one: 76
- X°Port Heart Preservation System (K261913): 510(k) cleared for Traferox Technologies, Inc.'s amount: 35th percentile of 414 records
- Timing: Low: older than 30 days
- Estimated pipeline if you contact every California peer: $15,200 (peers × rate × deal size; an estimate from your assumptions, not a forecast)
30 / 100 Predicate Speed & CAPA Advisory Opportunity Score
- Fast 100-day review: this device is a strong predicate for similar products.
What is the FDAPulse record for X°Port Heart Preservation System (K261913): 510(k) cleared for Traferox Technologies, Inc. in California?
X°Port Heart Preservation System (K261913) by Traferox Technologies, Inc. was cleared on 2026-09-16 after 100 days of review.
How does X°Port Heart Preservation System (K261913): 510(k) cleared for Traferox Technologies, Inc. compare to other California FDAPulse records?
Its amount of 100 is below the median (35th percentile); smaller records often move faster and face less competition. It is 49 days old; check the official source for later updates before acting. Its Predicate Speed & CAPA Advisory Opportunity Score of 30/100 is modest; treat it as background rather than a priority.
X°Port Heart Preservation System (K261913) vs. top 2 peers
| Organization | Location | Record date |
|---|---|---|
| X°Port Heart Preservation System (K261913) | CA | 2026-09-16 |
| CapsoView (CVV); CapsoCloud (CLD) (K254230) | CA | 2026-09-25 |
| Rapid Barostat Bag (RBB) Pump and Catheter System (K262621) | CA | 2026-09-30 |
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