Cleared Traditional

K844080 - ARROW-GEISS PERCUTANEOUS TPN KIT

K844080 is an FDA 510(k) clearance for ARROW-GEISS PERCUTANEOUS TPN KIT, manufactured by Arrow Intl., Inc.. The device is a Class 2 General Hospital device with product code LJS cleared through the Traditional 510(k) pathway after a 180-day FDA review.

K844080 · Arrow Intl., Inc. · General Hospital
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Apr 1985
Decision
180d
Days
Class 2
Risk

K844080 is an FDA 510(k) clearance for the ARROW-GEISS PERCUTANEOUS TPN KIT. Classified as Catheter, Intravascular, Therapeutic, Long-term Greater Than 30 Days (product code LJS), Class II - Special Controls.

Submitted by Arrow Intl., Inc. (Reading, US). The FDA issued a Cleared decision on April 17, 1985 after a review of 180 days - an extended review 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: 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 Arrow Intl., Inc. devices

FDA 510(k) Submission Details - K844080

510(k) Number K844080 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 19, 1984
Decision Date April 17, 1985
Days to Decision 180 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
51d slower than avg
Panel avg: 129d · This submission: 180d
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 190
Devices cleared under the same product code (LJS) and FDA review panel - the closest regulatory comparables to K844080.
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
ARGYLE SILICONE CENTRAL VENOUS CATH-
K843450 · Sherwood Medical Co. · Nov 1984
RIGHT ATRIAL CATHETER
K840742 · The Healthcare Group Laboratories, Inc. · Jul 1984
SHEATH REMOVER
K841878 · Datascope Corp. · Jul 1984