Cleared Traditional

K081904 - PRO-PICC (BASIC TRAY, LONG WIRE TRAY, BASIC NURSING TRAY, FULL NURSING TRAY)

K081904 is an FDA 510(k) clearance for PRO-PICC (BASIC TRAY, manufactured by Medcomp. The device is a Class 2 General Hospital device with product code LJS cleared through the Traditional 510(k) pathway after a 82-day FDA review.

K081904 · Medcomp · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2008
Decision
82d
Days
Class 2
Risk

K081904 is an FDA 510(k) clearance for the PRO-PICC (BASIC TRAY, LONG WIRE TRAY, BASIC NURSING TRAY, FULL NURSING TRAY). Classified as Catheter, Intravascular, Therapeutic, Long-term Greater Than 30 Days (product code LJS), Class II - Special Controls.

Submitted by Medcomp (Harleysville, US). The FDA issued a Cleared decision on September 23, 2008 after a review of 82 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 Medcomp devices

FDA 510(k) Submission Details - K081904

510(k) Number K081904 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 03, 2008
Decision Date September 23, 2008
Days to Decision 82 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
47d faster than avg
Panel avg: 129d · This submission: 82d
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 216
Devices cleared under the same product code (LJS) and FDA review panel - the closest regulatory comparables to K081904.
1.9F X 20CM VASCU-PICC, 1.9F X 50CM VASCU-PICC, MODEL VPI.9S20, VPI.9S50
K091466 · Medcomp · Jun 2009
NMI PICC
K091261 · Navilyst Medical, Inc. · May 2009
PICC (CT RATED AND NON-RATED)
K083873 · Pfm Medical, Inc. · Mar 2009
PRESSURE INJFECTABLE PICC
K080604 · Arrow International, Inc. · Jun 2008
PRESSURE INJECTABLE PICC
K073451 · Arrow International, Inc. · Jan 2008
TURBO-JECT PERIPHERALLY INSERTED CENTRAL VENOUS CATHETER (PICC)
K072625 · Cook, Inc. · Dec 2007