Cleared Traditional

K092040 - PHEROCIOUS 10.5 FR (24 CM, 28 CM AND 32 CM), MODELS 430102440, 430102840, 430103240

K092040 is an FDA 510(k) clearance for PHEROCIOUS 10.5 FR (24 CM, manufactured by R4 Vascular, Inc.. The device is a Class 2 General Hospital device with product code LJS cleared through the Traditional 510(k) pathway after a 139-day FDA review.

K092040 · R4 Vascular, Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2009
Decision
139d
Days
Class 2
Risk

K092040 is an FDA 510(k) clearance for the PHEROCIOUS 10.5 FR (24 CM, 28 CM AND 32 CM), MODELS 430102440, 430102840, 430.... Classified as Catheter, Intravascular, Therapeutic, Long-term Greater Than 30 Days (product code LJS), Class II - Special Controls.

Submitted by R4 Vascular, Inc. (Maple Grove, US). The FDA issued a Cleared decision on November 18, 2009 after a review of 139 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 R4 Vascular, Inc. devices

FDA 510(k) Submission Details - K092040

510(k) Number K092040 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 02, 2009
Decision Date November 18, 2009
Days to Decision 139 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
10d slower than avg
Panel avg: 129d · This submission: 139d
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 274
Devices cleared under the same product code (LJS) and FDA review panel - the closest regulatory comparables to K092040.
PRO-LINE CT (BASIC TRAY) MODEL MR28036101
K093309 · Medcomp ( Medical Components) · Nov 2009
NMI PICC II
K093366 · Navilyst Medical, Inc. · Nov 2009
VPS CATHETER
K091924 · Vasonova, Inc. · Nov 2009
PRO-PICC
K091953 · Medcomp · Sep 2009
PRO-PICC CT
K092347 · Medcomp · Sep 2009
FOOTPRINT MEDICAL PERIPHERALLY INSERTED CENTRAL CATHETER, MODEL S1PIC1.9-C
K091488 · Footprint Medical · Sep 2009