Cleared Traditional

K061285 - SMARTSITE NEEDLE FREE VALVE ADMINISTRATION SETS

K061285 is an FDA 510(k) clearance for SMARTSITE NEEDLE FREE VALVE ADMINISTRAT..., manufactured by Cardinal Health, Alaris Products. The device is a Class 2 General Hospital device with product code FPA cleared through the Traditional 510(k) pathway after a 79-day FDA review.

K061285 · Cardinal Health, Alaris Products · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2006
Decision
79d
Days
Class 2
Risk

K061285 is an FDA 510(k) clearance for the SMARTSITE NEEDLE FREE VALVE ADMINISTRATION SETS. Classified as Set, Administration, Intravascular (product code FPA), Class II - Special Controls.

Submitted by Cardinal Health, Alaris Products (San Diego, US). The FDA issued a Cleared decision on July 26, 2006 after a review of 79 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 Cardinal Health, Alaris Products devices

FDA 510(k) Submission Details - K061285

510(k) Number K061285 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 08, 2006
Decision Date July 26, 2006
Days to Decision 79 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
50d faster than avg
Panel avg: 129d · This submission: 79d
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 889
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