Cleared Traditional

K121089 - NMI PICC III

K121089 is an FDA 510(k) clearance for NMI PICC III, manufactured by Navilyst Medical, Inc.. The device is a Class 2 General Hospital device with product code LJS cleared through the Traditional 510(k) pathway after a 135-day FDA review.

K121089 · Navilyst Medical, Inc. · General Hospital
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Aug 2012
Decision
135d
Days
Class 2
Risk

K121089 is an FDA 510(k) clearance for the NMI PICC III. Classified as Catheter, Intravascular, Therapeutic, Long-term Greater Than 30 Days (product code LJS), Class II - Special Controls.

Submitted by Navilyst Medical, Inc. (Marlborough, US). The FDA issued a Cleared decision on August 23, 2012 after a review of 135 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 Navilyst Medical, Inc. devices

FDA 510(k) Submission Details - K121089

510(k) Number K121089 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 10, 2012
Decision Date August 23, 2012
Days to Decision 135 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
6d slower than avg
Panel avg: 129d · This submission: 135d
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 256
Devices cleared under the same product code (LJS) and FDA review panel - the closest regulatory comparables to K121089.
NMI HPICC III
K122882 · Navilyst Medical, Inc. · Oct 2012
CG+ ARROW PICC POWERED BY ARROW VPS STYLET
K122545 · Arrow International (Subsidiary of Teleflex Inc.) · Sep 2012
ARROW PICC POWERED BY ARROW VPS STYLET
K121941 · Arrow International (Subsidiary of Teleflex Inc.) · Sep 2012
PICC CONVENIENCE KIT
K121990 · Navilyst Medical, Inc. · Aug 2012
ARROWADVANTAGES PRESSURE INJECTABLE PERIPHERALLY INSCRTED CENTRAL CATHETER KITS
K113277 · Arrow International, Inc. · Jun 2012
MEDCOMP VASCU-PICC & MIDLINE CATHETERS
K121094 · Medical Components, Inc. · Jun 2012