Cleared Traditional

K923653 - NEEDLELESS INJECTION CANNULA

K923653 is an FDA 510(k) clearance for NEEDLELESS INJECTION CANNULA, 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 296-day FDA review.

K923653 · Arrow Intl., Inc. · General Hospital
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May 1993
Decision
296d
Days
Class 2
Risk

K923653 is an FDA 510(k) clearance for the NEEDLELESS INJECTION CANNULA. 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 May 13, 1993 after a review of 296 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 - K923653

510(k) Number K923653 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 21, 1992
Decision Date May 13, 1993
Days to Decision 296 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
167d slower than avg
Panel avg: 129d · This submission: 296d
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 K923653.
STRATO MEDICAL SINGLE LUMEN VALVED CATHETER
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STRATO MEDICAL INFUSE-A-CATH POLYURE CEN VEN CATH
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INFUSE-A-CATH SILICONE CENTRAL VENOUS CATHETER
K921751 · Strato Medical Corp. · Jul 1993
8 FR SINGLE LUMEN HIGH PERF. GROSHONG CENT. VENOUS
K921755 · Davol, Inc. · Oct 1992
8 FR SINGLE LUMEN HIGH PERFORMANCE CATHETER
K910486 · Davol, Inc. · Apr 1991
VYGON LIFEVAC PICC
K903648 · Vygon Corp. · Mar 1991