Cleared Traditional

UNI-PICC (K130034) - FDA 510(k) Clearance

Class II General Hospital device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

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

Submission Details

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.

Device Classification

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 96
Devices cleared under the same product code (LJS) and FDA review panel - the closest regulatory comparables to K130034.
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K132334 · Cook, Inc. · Aug 2013
THE SHERLOCK 3CG TIP CONFIRMATION SYSTEM (TCS)
K113808 · C.R. Bard, Inc. · Mar 2012
SAPIENS TIP CONFIRMATION SYSTEM
K112744 · C.R. Bard, Inc. · Oct 2011
TURBO-JECT PERIPHERALLY INSERTED CENTRAL VENOUS CATHETER (PICC)
K111244 · Cook, Inc. · Jun 2011