Cleared Traditional

K111381 - MEDI-SIS SYRINGE INFUSION SYSTEM (FDA 510(k) Clearance)

Class II General Hospital device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K111381 · Acacia, Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2012
Decision
241d
Days
Class 2
Risk

K111381 is an FDA 510(k) clearance for the MEDI-SIS SYRINGE INFUSION SYSTEM. Classified as Pump, Infusion, Enteral (product code LZH), Class II - Special Controls.

Submitted by Acacia, Inc. (Brea, US). The FDA issued a Cleared decision on January 13, 2012 after a review of 241 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 Acacia, Inc. devices

Submission Details

510(k) Number K111381 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 17, 2011
Decision Date January 13, 2012
Days to Decision 241 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
112d slower than avg
Panel avg: 129d · This submission: 241d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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.

Regulatory Peers - LZH Pump, Infusion, Enteral

All 33
Devices cleared under the same product code (LZH) and FDA review panel - the closest regulatory comparables to K111381.
Luminoah FLOW™ Enteral Nutrition System
K253558 · Luminoah · Apr 2026
Vesco Q™ Enteral Feeding Pump
K232205 · Vesco Medical, LLC · Oct 2023
Kangaroo OMNI™ Enteral Feeding Pump (385400 )
K221603 · Cardinal Health, LLC · Dec 2022
AMSure Enteral Feeding Pump
K220230 · Amsino International, Inc. · Nov 2022
PUGGLE Enteral Feeding Pump and Feeding Set
K200051 · Amsino International, Inc. · Sep 2020