Cleared Traditional

K912103 - LIFESHIELD EXTENSION SET

K912103 is an FDA 510(k) clearance for LIFESHIELD EXTENSION SET, manufactured by Abbott Laboratories. The device is a Class 2 General Hospital device with product code FPK cleared through the Traditional 510(k) pathway after a 214-day FDA review.

K912103 · Abbott Laboratories · General Hospital
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Dec 1991
Decision
214d
Days
Class 2
Risk

K912103 is an FDA 510(k) clearance for the LIFESHIELD EXTENSION SET. Classified as Tubing, Fluid Delivery (product code FPK), Class II - Special Controls.

Submitted by Abbott Laboratories (Abbott Park, US). The FDA issued a Cleared decision on December 13, 1991 after a review of 214 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 Abbott Laboratories devices

FDA 510(k) Submission Details - K912103

510(k) Number K912103 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 13, 1991
Decision Date December 13, 1991
Days to Decision 214 days
Submission Type Traditional
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
85d slower than avg
Panel avg: 129d · This submission: 214d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FPK Device Classification - Class 2, Special Controls

Product Code FPK Tubing, Fluid Delivery
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 - FPK Tubing, Fluid Delivery

All 22
Devices cleared under the same product code (FPK) and FDA review panel - the closest regulatory comparables to K912103.
POLYFIN EXTENSION SET, MODELS 126 AND 128
K965208 · Medtronic Minimed · Feb 1997
RECONSTITUTION ACCESSOREIS
K950861 · Organon, Inc. · May 1995
OPHTHALMIC FLUID DISTRIBUTION SETS
K923972 · Visitec Co. · Nov 1992
INTRAVASCULAR ADMINISTRATION SET MODEL 60040
K891009 · 3M Company · May 1989
INTRAVASCULAR ADMINI. SET MODELS 60030 & 60050
K891005 · 3M Company · May 1989
MERIT HI-FLEX(TM)
K883718 · Merit Medical Systems, Inc. · Jan 1989