Cleared Special

LIFESHIELD PRIMARY IV SET CONV. PIN. CLAVE (K030002) - FDA 510(k) Clearance

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

Class II General Hospital device cleared through the Special 510(k) pathway - typically does not require clinical trials.

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

Submission Details

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.

Device Classification

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 237
Devices cleared under the same product code (FPA) and FDA review panel - the closest regulatory comparables to K030002.
LIFESHIELD LATEX-FREE PRIMARY IV PUMP SET DISTAL MICROBORE PATIENT LINE, CONVERTIBLE PIN, 72 INCH, WITH 2 PRESSURE
K033576 · Abbott Laboratories · Dec 2003
BD VACUTAINER SAFETY-LOK ADMINISTRATION SET WITH FILTER
K033350 · Becton, Dickinson & CO · Nov 2003
ULTRASITE VALVE
K031923 · B.Braun Medical, Inc. · Aug 2003
SURECAN SAFETY HUBER NEEDLE INFUSION SETS
K021488 · B.Braun Medical, Inc. · Jul 2002
SURSHIELD SAFETY WINGED BLOOD COLLECTION SET
K013164 · Terumo Medical Corp. · Oct 2001
SURSHIELD WINGED INFUSION SET
K010103 · Terumo Medical Corp. · Mar 2001