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# 25G Huber Needle (K254095): 510(k) cleared for Martech Medical Products vs Pro-Line XL Power Injectable Central Venous Catheter and Pro-Line XL Tunneler (K260080): 510(k) cleared for Medical Components, Inc.: FDAPulse comparison

**25G Huber Needle (K254095): 510(k) cleared for Martech Medical Products's review days of 273 is 1.0x Pro-Line XL Power Injectable Central Venous Catheter and Pro-Line XL Tunneler (K260080): 510(k) cleared for Medical Components, Inc.'s 270 (95th percentile). 25G Huber Needle (K254095): 510(k) cleared for Martech Medical Products is dated 2026-09-18; Pro-Line XL Power Injectable Central Venous Catheter and Pro-Line XL Tunneler (K260080): 510(k) cleared for Medical Components, Inc. 2026-10-09.**

Data as of 2026-11-04 · [Compiled by Zalwin](/research/fdapulse) from U.S. FDA openFDA (510(k) clearances and device enforcement reports) Copy citation

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## How does 25G Huber Needle (K254095): 510(k) cleared for Martech Medical Products compare to Pro-Line XL Power Injectable Central Venous Catheter and Pro-Line XL Tunneler (K260080): 510(k) cleared for Medical Components, Inc.?

| Field | 25G Huber Needle (K254095): 510(k) cleared for Martech Medical Products | Pro-Line XL Power Injectable Central Venous Catheter and Pro-Line XL Tunneler (K260080): 510(k) cleared for Medical Components, Inc. |
|---|---|---|
| Record | 510(k) clearance | 510(k) clearance |
| 510(k) number | K254095 | K260080 |
| Device | 25G Huber Needle | Pro-Line XL Power Injectable Central Venous Catheter and Pro-Line XL Tunneler |
| Applicant | Martech Medical Products | Medical Components, Inc. |
| Specialty / panel | General Hospital | General Hospital |
| Product code | PTI | LJS |
| Device class | 2 | 2 |
| Clearance type | Traditional | Traditional |
| Decision | Substantially Equivalent | Substantially Equivalent |
| Received | 2025-12-19 | 2026-01-12 |
| Decision date | 2026-09-18 | 2026-10-09 |
| Review time (days) | 273 | 270 |
| Third-party review | No | No |
| Applicant location | Harleysville, PA, US | Harleysville, PA, US |
| amount percentile | 95th | 94th |
| Predicate Speed & CAPA Advisory Opportunity Score | 55/100 | 61/100 |
| Peer rank and all 500 records (CSV) | Every comparable record ranked, with amounts, dates and scores 🔒 Click to unlock → |
| Official source URLs for every peer record | Direct links to each record at its government source 🔒 Click to unlock → |

Official records: [25G Huber Needle (K254095): 510(k) cleared for Martech Medical Products](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K254095) · [Pro-Line XL Power Injectable Central Venous Catheter and Pro-Line XL Tunneler (K260080): 510(k) cleared for Medical Components, Inc.](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260080)

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Data from the FDA openFDA API, which may lag official FDA databases. Informational only; not regulatory or legal advice.

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