Cleared Traditional

K101329 - SYNERGY CT PICC

K101329 is an FDA 510(k) clearance for SYNERGY CT 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 99-day FDA review.

K101329 · Health Line International Corporation · General Hospital
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Aug 2010
Decision
99d
Days
Class 2
Risk

K101329 is an FDA 510(k) clearance for the SYNERGY CT 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 August 19, 2010 after a review of 99 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 Health Line International Corporation devices

FDA 510(k) Submission Details - K101329

510(k) Number K101329 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 12, 2010
Decision Date August 19, 2010
Days to Decision 99 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
30d faster than avg
Panel avg: 129d · This submission: 99d
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 K101329.
POWERPICC SV CATHETERS
K102159 · C.R. Bard, Inc. · Nov 2010
NMI IC
K101326 · Navilyst Medical, Inc. · Sep 2010
ARROWGARD EVOLUTION ANTIMICROBIAL PERIPHERALLY INSERTED CENTRAL CATHETER (PICC) MODEL: S-44041-002, S-45041-002, S-45504
K100635 · Arrow Intl., Inc. · Aug 2010
MORPHEUS SMART PICC CT AND PROCEDURE KIT MODEL 12105509, 12105519
K093406 · AngioDynamics, Inc. · Mar 2010
6F TRIPLE LUMEN POWERLINE CENTRAL VENOUS CATHETER, 5F DUAL LUMEN POWERLINE CENTRAL VENOUS CATHETER
K093927 · C.R. Bard, Inc. · Feb 2010
NMI PICC II
K093366 · Navilyst Medical, Inc. · Nov 2009