Cleared Traditional

K941214 - LIFESHIELD EXTENSION SET

K941214 is the FDA 510(k) clearance for LIFESHIELD EXTENSION SET by Abbott Mfg., Inc.. It is a Class 2 General Hospital device (product code FPK) cleared through the Traditional 510(k) pathway after a 207-day FDA review.

K941214 · Abbott Mfg., Inc. · General Hospital
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Oct 1994
Decision
207d
Days
Class 2
Risk

K941214 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 Mfg., Inc. (Abbott Park, US). The FDA issued a Cleared decision on October 3, 1994 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 Abbott Mfg., Inc. devices

Submission Details

510(k) Number K941214 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 10, 1994
Decision Date October 03, 1994
Days to Decision 207 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
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.

Device Classification

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 21
Devices cleared under the same product code (FPK) and FDA review panel - the closest regulatory comparables to K941214.
MEDRAD TRANSFER SET
K022431 · Medrad, Inc. · Sep 2002
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
LIFESHIELD EXTENSION SET
K912103 · Abbott Laboratories · Dec 1991
INTRAVASCULAR ADMINISTRATION SET MODEL 60040
K891009 · 3M Company · May 1989