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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 · Compiled by Zalwin from U.S. FDA openFDA (510(k) clearances and device enforcement reports)

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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.?

Field25G Huber Needle (K254095): 510(k) cleared for Martech Medical ProductsPro-Line XL Power Injectable Central Venous Catheter and Pro-Line XL Tunneler (K260080): 510(k) cleared for Medical Components, Inc.
Record510(k) clearance510(k) clearance
510(k) numberK254095K260080
Device25G Huber NeedlePro-Line XL Power Injectable Central Venous Catheter and Pro-Line XL Tunneler
ApplicantMartech Medical ProductsMedical Components, Inc.
Specialty / panelGeneral HospitalGeneral Hospital
Product codePTILJS
Device class22
Clearance typeTraditionalTraditional
DecisionSubstantially EquivalentSubstantially Equivalent
Received2025-12-192026-01-12
Decision date2026-09-182026-10-09
Review time (days)273270
Third-party reviewNoNo
Applicant locationHarleysville, PA, USHarleysville, PA, US
amount percentile95th94th
Predicate Speed & CAPA Advisory Opportunity Score55/10061/100
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Official records: 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.

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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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