Cleared Traditional

K882100 - VITACUFF PERCUTANEOUS INFECT. CONTROL KIT

K882100 is an FDA 510(k) clearance for VITACUFF PERCUTANEOUS INFECT. CONTROL KIT, manufactured by Vitaphore Corp.. The device is a Class 2 General Hospital device with product code LJS cleared through the Traditional 510(k) pathway after a 55-day FDA review.

K882100 · Vitaphore Corp. · General Hospital
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Jul 1988
Decision
55d
Days
Class 2
Risk

K882100 is an FDA 510(k) clearance for the VITACUFF(R) PERCUTANEOUS INFECT. CONTROL KIT. Classified as Catheter, Intravascular, Therapeutic, Long-term Greater Than 30 Days (product code LJS), Class II - Special Controls.

Submitted by Vitaphore Corp. (San Carlos, US). The FDA issued a Cleared decision on July 13, 1988 after a review of 55 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 Vitaphore Corp. devices

FDA 510(k) Submission Details - K882100

510(k) Number K882100 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 19, 1988
Decision Date July 13, 1988
Days to Decision 55 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
74d faster than avg
Panel avg: 129d · This submission: 55d
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 194
Devices cleared under the same product code (LJS) and FDA review panel - the closest regulatory comparables to K882100.
DUAL LUMEN CATHETER FOR CHRONIC VASCULAR ACCESS
K892926 · Vas-Cath, Inc. · Dec 1989
DESERET(R) INTRODUCER SET WITH VITACUFF(R) DEVICE
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MULTILUMEN CENTRAL VENOUS CATH. W/VITACUFF DEVICE
K882448 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Aug 1988
VAPOR-SEAL(TM) PERCUTANEOUS CATHETERS
K864086 · Pharmacia, Inc. · Apr 1987
GRECO-HARVEY SURFACT BOND CATH HYPERALIMENTATION
K851243 · Cook, Inc. · Mar 1986
VASCULAR ACCESS CATHETER
K851195 · Sil-Med Corp. · Jun 1985