Cleared Traditional

K910486 - 8 FR SINGLE LUMEN HIGH PERFORMANCE CATH...

K910486 is the FDA 510(k) clearance for 8 FR SINGLE LUMEN HIGH PERFORMANCE CATH... by Davol, Inc.. It is a Class 2 General Hospital device (product code LJS) cleared through the Traditional 510(k) pathway after a 72-day FDA review.

K910486 · Davol, Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1991
Decision
72d
Days
Class 2
Risk

K910486 is an FDA 510(k) clearance for the 8 FR SINGLE LUMEN HIGH PERFORMANCE CATHETER. Classified as Catheter, Intravascular, Therapeutic, Long-term Greater Than 30 Days (product code LJS), Class II - Special Controls.

Submitted by Davol, Inc. (Salt Lake City, US). The FDA issued a Cleared decision on April 19, 1991 after a review of 72 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 Davol, Inc. devices

Submission Details

510(k) Number K910486 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 06, 1991
Decision Date April 19, 1991
Days to Decision 72 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
57d faster than avg
Panel avg: 129d · This submission: 72d
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 180
Devices cleared under the same product code (LJS) and FDA review panel - the closest regulatory comparables to K910486.
INFUSE-A-CATH SILICONE CENTRAL VENOUS CATHETER
K921751 · Strato Medical Corp. · Jul 1993
NEEDLELESS INJECTION CANNULA
K923653 · Arrow Intl., Inc. · May 1993
8 FR SINGLE LUMEN HIGH PERF. GROSHONG CENT. VENOUS
K921755 · Davol, Inc. · Oct 1992
VYGON LIFEVAC PICC
K903648 · Vygon Corp. · Mar 1991
PERCUTANEOUS INTRAVENOUS CATHETER REPAIR KIT
K904334 · Pharmacia Deltec, Inc. · Nov 1990
WIGNESS-BUCHWALD CENTRAL VENOUS ACCESS CATHETER
K895543 · Strato Medical Corp. · Sep 1990