Cleared Traditional

K122423 - VASU-PICC

K122423 is an FDA 510(k) clearance for VASU-PICC, manufactured by Medical Components, Inc.. The device is a Class 2 General Hospital device with product code LJS cleared through the Traditional 510(k) pathway after a 125-day FDA review.

K122423 · Medical Components, Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2012
Decision
125d
Days
Class 2
Risk

K122423 is an FDA 510(k) clearance for the VASU-PICC. Classified as Catheter, Intravascular, Therapeutic, Long-term Greater Than 30 Days (product code LJS), Class II - Special Controls.

Submitted by Medical Components, Inc. (Harleysville, US). The FDA issued a Cleared decision on December 12, 2012 after a review of 125 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 Medical Components, Inc. devices

FDA 510(k) Submission Details - K122423

510(k) Number K122423 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 09, 2012
Decision Date December 12, 2012
Days to Decision 125 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
4d faster than avg
Panel avg: 129d · This submission: 125d
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 193
Devices cleared under the same product code (LJS) and FDA review panel - the closest regulatory comparables to K122423.
NMI PICC III CATHETER, NMI HPICC III CATHETER
K131942 · Navilyst Medical, Inc. · Jul 2013
3F PRO-PICC
K123617 · Medical Components, Inc. · May 2013
NMI PICC MAXIMAL BARRIER NURSING KITS
K131038 · Navilyst Medical, Inc. · May 2013
NMI HPICC III
K122882 · Navilyst Medical, Inc. · Oct 2012
NMI PICC III
K121089 · Navilyst Medical, Inc. · Aug 2012
PICC CONVENIENCE KIT
K121990 · Navilyst Medical, Inc. · Aug 2012