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) Official FDA 510(k) Summary (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.

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
Combination Product No
PCCP Authorized No
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 Consultant

Salus Ventures, LLC
Jim Lewis

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - LJS Catheter, Intravascular, Therapeutic, Long-term Greater Than 30 Days

All 291
Devices cleared under the same product code (LJS) and FDA review panel - the closest regulatory comparables to K152261.
Amecath Peripheral inserted Central Venous Catheter Sets
K152819 · Ameco Medical Industries · Feb 2016
CG+ Arrow PICC powered by Arrow VPS Stylet PLUS and Arrow VPS Stylet PLUS
K153487 · Arrow International, Inc. (Subsidiary of Teleflex, Inc.) · Feb 2016
CG+ Arrow JACC powered by Arrow VPS Stylet, CG+ Arrow JACC
K153423 · Arrow International, Inc. (Subsidiary of Teleflex, Inc.) · Jan 2016
Xcela PICC with PASV, Xcela Hybrid PICC with PASV, Xcela Power Injectable PICC
K152409 · Navilyst Medical, Inc. · Sep 2015
C3 Wave
K143238 · Medcomp ( Medical Components) · Apr 2015
Xcela Power Injectable PICC
K150527 · Navilyst Medical, Inc. · Mar 2015
K152261 · PICC Tip Positioning Aid
Download PDF FDA Summary Nostix, LLC