Cleared Special

K030002 - LIFESHIELD PRIMARY IV SET CONV. PIN. CLAVE

Also marketed or referenced as:
LF LC 5000 PLUMSET-DUAL W/CONV PIN & CAP PORT LIFESHIELD LF MACROBORE EXT.

K030002 is an FDA 510(k) clearance for LIFESHIELD PRIMARY IV SET CONV. PIN. CLAVE, manufactured by Abbott Laboratories. The device is a Class 2 General Hospital device with product code FPA cleared through the Special 510(k) pathway after a 25-day FDA review.

K030002 · Abbott Laboratories · General Hospital
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Jan 2003
Decision
25d
Days
Class 2
Risk

K030002 is an FDA 510(k) clearance for the LIFESHIELD PRIMARY IV SET CONV. PIN. CLAVE. Classified as Set, Administration, Intravascular (product code FPA), Class II - Special Controls.

Submitted by Abbott Laboratories (Abbott Park, US). The FDA issued a Cleared decision on January 27, 2003 after a review of 25 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Abbott Laboratories devices

FDA 510(k) Submission Details - K030002

510(k) Number K030002 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 02, 2003
Decision Date January 27, 2003
Days to Decision 25 days
Submission Type Special
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
104d faster than avg
Panel avg: 129d · This submission: 25d
Pathway characteristics
Modification to existing cleared device.

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 532
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