Cleared Traditional

K904013 - SPIVE NEEDLE SYSTEM, MODIFICATION

K904013 is an FDA 510(k) clearance for SPIVE NEEDLE SYSTEM, manufactured by Pascall Medical Corp.. The device is a Class 2 General Hospital device with product code FPA cleared through the Traditional 510(k) pathway after a 33-day FDA review.

K904013 · Pascall Medical Corp. · General Hospital
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Oct 1990
Decision
33d
Days
Class 2
Risk

K904013 is an FDA 510(k) clearance for the SPIVE NEEDLE SYSTEM, MODIFICATION. Classified as Set, Administration, Intravascular (product code FPA), Class II - Special Controls.

Submitted by Pascall Medical Corp. (Bethesda, US). The FDA issued a Cleared decision on October 1, 1990 after a review of 33 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 Pascall Medical Corp. devices

FDA 510(k) Submission Details - K904013

510(k) Number K904013 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 29, 1990
Decision Date October 01, 1990
Days to Decision 33 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
96d faster than avg
Panel avg: 129d · This submission: 33d
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 835
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