Cleared Traditional

K071400 - SMARTSITE STOPCOCK

K071400 is an FDA 510(k) clearance for SMARTSITE STOPCOCK, manufactured by Cardinal Health, Alaris Products. The device is a Class 2 General Hospital device with product code FMG cleared through the Traditional 510(k) pathway after a 207-day FDA review.

K071400 · Cardinal Health, Alaris Products · General Hospital
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Dec 2007
Decision
207d
Days
Class 2
Risk

K071400 is an FDA 510(k) clearance for the SMARTSITE STOPCOCK. Classified as Stopcock, I.v. Set (product code FMG), Class II - Special Controls.

Submitted by Cardinal Health, Alaris Products (San Diego, US). The FDA issued a Cleared decision on December 14, 2007 after a review of 207 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all Cardinal Health, Alaris Products devices

FDA 510(k) Submission Details - K071400

510(k) Number K071400 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 21, 2007
Decision Date December 14, 2007
Days to Decision 207 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
78d slower than avg
Panel avg: 129d · This submission: 207d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FMG Device Classification - Class 2, Special Controls

Product Code FMG Stopcock, I.v. Set
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 - FMG Stopcock, I.v. Set

All 60
Devices cleared under the same product code (FMG) and FDA review panel - the closest regulatory comparables to K071400.
ICU MEDICAL UNIVERSAL SINGLE-USE SPIKES
K082836 · Icu Medical, Inc. · Feb 2009
ELCAM ANTIMICROBIAL CLOSED STOPCOCKS (DSS AND TSS)
K082106 · Elcam Medical Acal · Oct 2008
CLAVE STOPCOCK
K080077 · Icu Medical, Inc. · Feb 2008
JMS PLANECTA STOPCOCK
K070143 · Jms North America Corp. · Apr 2007
BACSTOP
K053405 · Elcam Medical Acal · May 2006
ROBERTSITE STOPCOCK
K061143 · Halkey-Roberts Corp. · May 2006