Cleared Traditional

K913958 - FLEXIFLO QUANTUM ENTERAL NUTRITION PUMP

K913958 is an FDA 510(k) clearance for FLEXIFLO QUANTUM ENTERAL NUTRITION PUMP, manufactured by Abbott Laboratories. The device is a Class 2 General Hospital device with product code LZH cleared through the Traditional 510(k) pathway after a 155-day FDA review.

K913958 · Abbott Laboratories · General Hospital
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Feb 1992
Decision
155d
Days
Class 2
Risk

K913958 is an FDA 510(k) clearance for the FLEXIFLO QUANTUM ENTERAL NUTRITION PUMP. Classified as Pump, Infusion, Enteral (product code LZH), Class II - Special Controls.

Submitted by Abbott Laboratories (Columbus, US). The FDA issued a Cleared decision on February 7, 1992 after a review of 155 days - an extended review cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5725 - 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 - K913958

510(k) Number K913958 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 05, 1991
Decision Date February 07, 1992
Days to Decision 155 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
26d slower than avg
Panel avg: 129d · This submission: 155d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LZH Device Classification - Class 2, Special Controls

Product Code LZH Pump, Infusion, Enteral
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5725
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 - LZH Pump, Infusion, Enteral

All 11
Devices cleared under the same product code (LZH) and FDA review panel - the closest regulatory comparables to K913958.
KANGAROO ENTERAL FEEDING SET WITH ENFIT CONNECTORS
K141479 · Covidien · Dec 2014
KANGAROO(R) 524 ENTERAL FEEDING PUMP AND ADMINISTRATION SETS
K945964 · Sherwood Medical Co. · Mar 1995
FLO-GARD 2100 - 2M8281M
K923066 · Baxter Healthcare Corp · May 1993
KANGAROO(R) PET(TM) ENTERAL FEED PUMP/CHARGER BASE
K913413 · Sherwood Medical Co. · Nov 1991