Cleared Traditional

K802329 - DISPOSABLE CONSTRAST DELIVERY SPIKE KIT

K802329 is an FDA 510(k) clearance for DISPOSABLE CONSTRAST DELIVERY SPIKE KIT, manufactured by Stanco Medical, Inc.. The device is a Class 2 General Hospital device with product code FPA cleared through the Traditional 510(k) pathway after a 10-day FDA review.

K802329 · Stanco Medical, Inc. · General Hospital
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Oct 1980
Decision
10d
Days
Class 2
Risk

K802329 is an FDA 510(k) clearance for the DISPOSABLE CONSTRAST DELIVERY SPIKE KIT. Classified as Set, Administration, Intravascular (product code FPA), Class II - Special Controls.

Submitted by Stanco Medical, Inc. (Walker, US). The FDA issued a Cleared decision on October 3, 1980 after a review of 10 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5440 - 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 Stanco Medical, Inc. devices

FDA 510(k) Submission Details - K802329

510(k) Number K802329 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 23, 1980
Decision Date October 03, 1980
Days to Decision 10 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
119d faster than avg
Panel avg: 129d · This submission: 10d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FPA Device Classification - Class 2, Special Controls

Product Code FPA Set, Administration, Intravascular
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5440
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 - FPA Set, Administration, Intravascular

All 657
Devices cleared under the same product code (FPA) and FDA review panel - the closest regulatory comparables to K802329.
VENTED PRIMARY PIGGYBACK VENOSET DUAL
K810239 · Abbott Laboratories · May 1981
NITROGLYCERINE IV SET
K810317 · Abbott Laboratories · May 1981
HAEMONETICS 170 Y INFUSION SET
K810365 · Haemonetics Corp. · Mar 1981
PRIMARY SOLUTION ADMIN. SET-#86-01-0 260
K801871 · Y · Aug 1980
MODEL 86-01-1 260 SOLUTION ADMIN. SET
K801872 · Y · Aug 1980
MODEL 86-21-0 260 SECONDARY MEDICATION
K801873 · Y · Aug 1980