Cleared Traditional

K152819 - Amecath Peripheral inserted Central Venous Catheter Sets

K152819 is an FDA 510(k) clearance for Amecath Peripheral inserted Central Ven..., manufactured by Ameco Medical Industries. The device is a Class 2 General Hospital device with product code LJS cleared through the Traditional 510(k) pathway after a 130-day FDA review.

K152819 · Ameco Medical Industries · General Hospital
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Feb 2016
Decision
130d
Days
Class 2
Risk

K152819 is an FDA 510(k) clearance for the Amecath Peripheral inserted Central Venous Catheter Sets. Classified as Catheter, Intravascular, Therapeutic, Long-term Greater Than 30 Days (product code LJS), Class II - Special Controls.

Submitted by Ameco Medical Industries (10th Of Ramadan City, EG). The FDA issued a Cleared decision on February 5, 2016 after a review of 130 days - within the typical 510(k) review window.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5970 - the FDA general hospital device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all Ameco Medical Industries devices

FDA 510(k) Submission Details - K152819

510(k) Number K152819 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 28, 2015
Decision Date February 05, 2016
Days to Decision 130 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
1d slower than avg
Panel avg: 129d · This submission: 130d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LJS Device Classification - Class 2, Special Controls

Product Code LJS Catheter, Intravascular, Therapeutic, Long-term Greater Than 30 Days
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5970
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General Hospital devices follow this clearance model.

Regulatory Consultant

Licensale, Inc.
Ray Kelly

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - LJS Catheter, Intravascular, Therapeutic, Long-term Greater Than 30 Days

All 274
Devices cleared under the same product code (LJS) and FDA review panel - the closest regulatory comparables to K152819.
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K151985 · C.R. Bard, Inc. · Jun 2016
CG+ Arrow PICC powered by Arrow VPS Stylet PLUS and Arrow VPS Stylet PLUS
K153487 · Arrow International, Inc. (Subsidiary of Teleflex, Inc.) · Feb 2016
CG+ Arrow JACC powered by Arrow VPS Stylet, CG+ Arrow JACC
K153423 · Arrow International, Inc. (Subsidiary of Teleflex, Inc.) · Jan 2016
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K152261 · Nostix, LLC · Oct 2015