Cleared Traditional

K130034 - UNI-PICC

K130034 is an FDA 510(k) clearance for UNI-PICC, manufactured by Health Line International Corporation. The device is a Class 2 General Hospital device with product code LJS cleared through the Traditional 510(k) pathway after a 60-day FDA review.

K130034 · Health Line International Corporation · General Hospital
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Mar 2013
Decision
60d
Days
Class 2
Risk

K130034 is an FDA 510(k) clearance for the UNI-PICC. Classified as Catheter, Intravascular, Therapeutic, Long-term Greater Than 30 Days (product code LJS), Class II - Special Controls.

Submitted by Health Line International Corporation (Centerville, US). The FDA issued a Cleared decision on March 8, 2013 after a review of 60 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Health Line International Corporation devices

FDA 510(k) Submission Details - K130034

510(k) Number K130034 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 07, 2013
Decision Date March 08, 2013
Days to Decision 60 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
69d faster than avg
Panel avg: 129d · This submission: 60d
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 Peers - LJS Catheter, Intravascular, Therapeutic, Long-term Greater Than 30 Days

All 194
Devices cleared under the same product code (LJS) and FDA review panel - the closest regulatory comparables to K130034.
NMI PICC III CATHETER, NMI HPICC III CATHETER
K131942 · Navilyst Medical, Inc. · Jul 2013
3F PRO-PICC
K123617 · Medical Components, Inc. · May 2013
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K131038 · Navilyst Medical, Inc. · May 2013
VASU-PICC
K122423 · Medical Components, Inc. · Dec 2012
NMI HPICC III
K122882 · Navilyst Medical, Inc. · Oct 2012
NMI PICC III
K121089 · Navilyst Medical, Inc. · Aug 2012