Cleared Traditional

K963070 - VENIPUNCTURE KIT

K963070 is an FDA 510(k) clearance for VENIPUNCTURE KIT, manufactured by Miller Products and Services. The device is a Class 2 General Hospital device with product code FPA cleared through the Traditional 510(k) pathway after a 37-day FDA review.

K963070 · Miller Products and Services · General Hospital
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Sep 1996
Decision
37d
Days
Class 2
Risk

K963070 is an FDA 510(k) clearance for the VENIPUNCTURE KIT. Classified as Set, Administration, Intravascular (product code FPA), Class II - Special Controls.

Submitted by Miller Products and Services (Charlotte, US). The FDA issued a Cleared decision on September 13, 1996 after a review of 37 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 Miller Products and Services devices

FDA 510(k) Submission Details - K963070

510(k) Number K963070 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 07, 1996
Decision Date September 13, 1996
Days to Decision 37 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
92d faster than avg
Panel avg: 129d · This submission: 37d
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 770
Devices cleared under the same product code (FPA) and FDA review panel - the closest regulatory comparables to K963070.
DELTEC SUBCUTANEOUS INFUSION SET
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SAFE MATE I.V. EXTENSION SETS
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SAFE MATE I.V. FLUID DELIVERY SETS
K962802 · Biological & Environmental Control Laboratories · Aug 1996
FLUID ADMINISTRATION SET - CONTRAST MANAGER
K961794 · Merit Medical Systems, Inc. · Aug 1996