Cleared Traditional

5 FR Dual Lumen Piper PICC (K181904) - FDA 510(k) Clearance

Class II General Hospital device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K181904 · Piper Access, LLC · General Hospital
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Sep 2018
Decision
71d
Days
Class 2
Risk

K181904 is an FDA 510(k) clearance for the 5 FR Dual Lumen Piper PICC. Classified as Catheter, Intravascular, Therapeutic, Long-term Greater Than 30 Days (product code LJS), Class II - Special Controls.

Submitted by Piper Access, LLC (Salt Lake City, US). The FDA issued a Cleared decision on September 25, 2018 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 Piper Access, LLC devices

Submission Details

510(k) Number K181904 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 16, 2018
Decision Date September 25, 2018
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.

Device Classification

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 89
Devices cleared under the same product code (LJS) and FDA review panel - the closest regulatory comparables to K181904.
Biowy PICC Catheter S Kit
K192246 · Biowy Corporation · Apr 2020
HydroPICC (PICC-142)
K193015 · Access Vascular, Inc. · Feb 2020
Jet Power Injectable PICC
K180546 · Jet Medical, Inc. · Nov 2018
Sherlock 3CG+ T ip Confirmation System
K180560 · C.R. Bard, Inc. · Jun 2018
Biowy PlCC Catheter
K173956 · Biowy Corporation · May 2018
3F Single Lumen and 4F Dual Lumen PowerPICC Provena Catherers
K180548 · C.R. Bard, Inc (Bard Has Joined Bd) · Apr 2018