Pro-Line XL Power Injectable Central Venous Catheter and Pro-Line XL Tunneler (K260080): 510(k) cleared for Medical Components, Inc.
Pro-Line XL Power Injectable Central Venous Catheter and Pro-Line XL Tunneler (K260080): 510(k) cleared for Medical Components, Inc. (Pennsylvania): 510(k) cleared for Medical Components, Inc. Its amount of 270 is top-decile (94th percentile of 414 records). Dated 26 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: 270 · 94th percentile of 414 FDAPulse records · 2.0x the median
Free preview: all 14 published fields of this record are shown below. Locked: 18 related PA FDAPulse records and the 5-column CSV export.
| Field | Value |
|---|---|
| Record | 510(k) clearance |
| 510(k) number | K260080 |
| Device | Pro-Line XL Power Injectable Central Venous Catheter and Pro-Line XL Tunneler |
| Applicant | Medical Components, Inc. |
| Specialty / panel | General Hospital |
| Product code | LJS |
| Device class | 2 |
| Clearance type | Traditional |
| Decision | Substantially Equivalent |
| Received | 2026-01-12 |
| Decision date | 2026-10-09 |
| Review time (days) | 270 |
| Third-party review | No |
| Applicant location | Harleysville, PA, US |
| amount percentile | 94th of 414 (median 138, 2.0x median) |
| Peer records CSV (19 PA records) | 🔒 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: 2026-10-09
- Data refreshed: 2026-11-04
- Refunds on request within 14 days
Top FDAPulse records (PA first): 25G Huber Needle (K254095) · VacHeal Negative Pressure Wound Therapy System (K254160) · Ventricular Catheters, Thomale Catheter (K260044) · Gravity Blood Sets with 200µm Filter (K260261) · BoneVue (K254072) · 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: Pro-Line XL Power Injectable Central Venous Catheter and Pro-Line XL Tunneler (K260080): 510(k) cleared for Medical Components, Inc. and 19 Pennsylvania peers
- Pennsylvania FDAPulse records like this one: 19
- Pro-Line XL Power Injectable Central Venous Catheter and Pro-Line XL Tunneler (K260080): 510(k) cleared for Medical Components, Inc.'s amount: 94th percentile of 414 records
- Timing: Medium: dated in the last 30 days
- Estimated pipeline if you contact every Pennsylvania peer: $3,800 (peers × rate × deal size; an estimate from your assumptions, not a forecast)
61 / 100 Predicate Speed & CAPA Advisory Opportunity Score
- A long 270-day review suggests additional-information requests: a firm likely to value regulatory help next time.
- Posted 26 days ago.
What is the FDAPulse record for Pro-Line XL Power Injectable Central Venous Catheter and Pro-Line XL Tunneler (K260080): 510(k) cleared for Medical Components, Inc. in Pennsylvania?
Pro-Line XL Power Injectable Central Venous Catheter and Pro-Line XL Tunneler (K260080) by Medical Components, Inc. was cleared on 2026-10-09 after 270 days of review.
How does Pro-Line XL Power Injectable Central Venous Catheter and Pro-Line XL Tunneler (K260080): 510(k) cleared for Medical Components, Inc. compare to other Pennsylvania FDAPulse records?
This is a top-decile record: its amount of 270 is 2.0x the median of 138 across 414 records. It is 26 days old, still within a typical 45-day follow-up window.
Pro-Line XL Power Injectable Central Venous Catheter and Pro-Line XL Tunneler (K260080) vs. top 2 peers
| Organization | Location | Record date |
|---|---|---|
| Pro-Line XL Power Injectable Central Venous Catheter and Pro-Line XL Tunneler (K260080) | PA | 2026-10-09 |
| Gravity Blood Sets with 200µm Filter (K260261) | PA | 2026-10-22 |
| 25G Huber Needle (K254095) | PA | 2026-09-18 |
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