Cleared Traditional

K851243 - GRECO-HARVEY SURFACT BOND CATH HYPERALIMENTATION

K851243 is an FDA 510(k) clearance for GRECO-HARVEY SURFACT BOND CATH HYPERALI..., manufactured by Cook, Inc.. The device is a Class 2 General Hospital device with product code LJS cleared through the Traditional 510(k) pathway after a 381-day FDA review.

K851243 · Cook, Inc. · General Hospital
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Mar 1986
Decision
381d
Days
Class 2
Risk

K851243 is an FDA 510(k) clearance for the GRECO-HARVEY SURFACT BOND CATH HYPERALIMENTATION. Classified as Catheter, Intravascular, Therapeutic, Long-term Greater Than 30 Days (product code LJS), Class II - Special Controls.

Submitted by Cook, Inc. (New Brunswick, US). The FDA issued a Cleared decision on March 14, 1986 after a review of 381 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: Standard predicate-based submission. Elevated predicate reliance profile. 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 Cook, Inc. devices

FDA 510(k) Submission Details - K851243

510(k) Number K851243 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 26, 1985
Decision Date March 14, 1986
Days to Decision 381 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
252d slower than avg
Panel avg: 129d · This submission: 381d
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 257
Devices cleared under the same product code (LJS) and FDA review panel - the closest regulatory comparables to K851243.
PMT VASCULAR CATHETER MODEL NUMBER 3621-1
K883313 · Pmt Corp. · Oct 1988
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
VASCULAR ACCESS CATHETER
K851195 · Sil-Med Corp. · Jun 1985
ARROW-GEISS PERCUTANEOUS TPN KIT
K844080 · Arrow Intl., Inc. · Apr 1985
ARGYLE SILICONE CENTRAL VENOUS CATH-
K843450 · Sherwood Medical Co. · Nov 1984