Cleared Traditional

K152261 - PICC Tip Positioning Aid

K152261 is an FDA 510(k) clearance for PICC Tip Positioning Aid, manufactured by Nostix, LLC. The device is a Class 2 General Hospital device with product code LJS cleared through the Traditional 510(k) pathway after a 71-day FDA review.

K152261 · Nostix, LLC · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2015
Decision
71d
Days
Class 2
Risk

K152261 is an FDA 510(k) clearance for the PICC Tip Positioning Aid. Classified as Catheter, Intravascular, Therapeutic, Long-term Greater Than 30 Days (product code LJS), Class II - Special Controls.

Submitted by Nostix, LLC (Boulder, US). The FDA issued a Cleared decision on October 21, 2015 after a review of 71 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 Nostix, LLC devices

FDA 510(k) Submission Details - K152261

510(k) Number K152261 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 11, 2015
Decision Date October 21, 2015
Days to Decision 71 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
58d faster than avg
Panel avg: 129d · This submission: 71d
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 209
Devices cleared under the same product code (LJS) and FDA review panel - the closest regulatory comparables to K152261.
PowerPICC Provena Catheters
K162443 · C.R. Bard, Inc. · Oct 2016
Turbo-Flo PICC Sets
K161496 · Cook Incorporated · Oct 2016
PowerPICC® EtOH Catheter and PowerPICC SOLO®2 EtOH Catheter
K151985 · C.R. Bard, Inc. · Jun 2016
Xcela PICC with PASV, Xcela Hybrid PICC with PASV, Xcela Power Injectable PICC
K152409 · Navilyst Medical, Inc. · Sep 2015
Xcela Power Injectable PICC
K150527 · Navilyst Medical, Inc. · Mar 2015
NMI PICC III and NMI PICC IV
K150448 · Navilyst Medical, Inc. · Mar 2015