Cleared Special

K131154 - ENTERALITE INFINITY SPIKE ENTERAL DELIVERY SET (FDA 510(k) Clearance)

Also includes:
ENTERALITE INFINITY 500 ML BAG ENTERAL DELIVERY SET

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

K131154 · Zevex, Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2014
Decision
294d
Days
Class 2
Risk

K131154 is an FDA 510(k) clearance for the ENTERALITE INFINITY SPIKE ENTERAL DELIVERY SET. Classified as Pump, Infusion, Enteral (product code LZH), Class II - Special Controls.

Submitted by Zevex, Inc. (Salt Lake City, US). The FDA issued a Cleared decision on February 12, 2014 after a review of 294 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. 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. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Zevex, Inc. devices

Submission Details

510(k) Number K131154 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 24, 2013
Decision Date February 12, 2014
Days to Decision 294 days
Submission Type Special
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
166d slower than avg
Panel avg: 128d · This submission: 294d
Pathway characteristics
Modification to existing cleared device.

Device Classification

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.