Cleared Traditional

K011216 - PVC FREE INTRAVASCULAR ADMINISTRATION SET

K011216 is an FDA 510(k) clearance for PVC FREE INTRAVASCULAR ADMINISTRATION SET, manufactured by Biometrix , Ltd.. The device is a Class 2 General Hospital device with product code FPA cleared through the Traditional 510(k) pathway after a 89-day FDA review.

K011216 · Biometrix , Ltd. · General Hospital
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Jul 2001
Decision
89d
Days
Class 2
Risk

K011216 is an FDA 510(k) clearance for the PVC FREE INTRAVASCULAR ADMINISTRATION SET. Classified as Set, Administration, Intravascular (product code FPA), Class II - Special Controls.

Submitted by Biometrix , Ltd. (Jerusalem, IL). The FDA issued a Cleared decision on July 18, 2001 after a review of 89 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 Biometrix , Ltd. devices

FDA 510(k) Submission Details - K011216

510(k) Number K011216 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 20, 2001
Decision Date July 18, 2001
Days to Decision 89 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
40d faster than avg
Panel avg: 129d · This submission: 89d
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 574
Devices cleared under the same product code (FPA) and FDA review panel - the closest regulatory comparables to K011216.
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