Cleared Traditional

K926331 - 3.0 FR GROSHONG PERIPHER INSERT CENT VE...

K926331 is the FDA 510(k) clearance for 3.0 FR GROSHONG PERIPHER INSERT CENT VE... by Bard Access Systems, Inc.. It is a Class 2 General Hospital device (product code LJS) cleared through the Traditional 510(k) pathway after a 446-day FDA review.

K926331 · Bard Access Systems, Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1994
Decision
446d
Days
Class 2
Risk

K926331 is an FDA 510(k) clearance for the 3.0 FR GROSHONG PERIPHER INSERT CENT VENOUS CATH. Classified as Catheter, Intravascular, Therapeutic, Long-term Greater Than 30 Days (product code LJS), Class II - Special Controls.

Submitted by Bard Access Systems, Inc. (Salt Lake City, US). The FDA issued a Cleared decision on March 7, 1994 after a review of 446 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind General Hospital submissions.

View all Bard Access Systems, Inc. devices

Submission Details

510(k) Number K926331 FDA.gov
FDA Decision Cleared Substantially Equivalent - De Novo Granted (SEKD)
Date Received December 16, 1992
Decision Date March 07, 1994
Days to Decision 446 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
317d slower than avg
Panel avg: 129d · This submission: 446d
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 181
Devices cleared under the same product code (LJS) and FDA review panel - the closest regulatory comparables to K926331.
PHERIPHERALLY INSERTED VENOUS CATHETER-Y SITE
K932433 · Pharmacia Deltec, Inc. · May 1994
PERIPHERALLYINSRTED VENOUS CATH. ALTERNATE CATH.
K932464 · Pharmacia Deltec, Inc. · May 1994
ARROW PICC-PERIPHERALLY INSERTED CENTRAL CATHETER
K930129 · Arrow Intl., Inc. · Mar 1994
RIGHT ATRIAL CATHETER
K930630 · Akcess Medical Products, Inc. · Feb 1994
STRATO MEDICAL LIFEPORT LPS 7255 LOW PROFILE DUAL LUMEN VASCULAR ACCESS SYSTEM
K933884 · Strato Medical Corp. · Dec 1993
STRATO MEDICAL SINGLE LUMEN VALVED CATHETER
K924851 · Strato Medical Corp. · Dec 1993