Cleared Traditional

K111381 - MEDI-SIS SYRINGE INFUSION SYSTEM

K111381 is an FDA 510(k) clearance for MEDI-SIS SYRINGE INFUSION SYSTEM, manufactured by Acacia, Inc.. The device is a Class 2 General Hospital device with product code LZH cleared through the Traditional 510(k) pathway after a 241-day FDA review.

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

FDA 510(k) Submission Details - K111381

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
Combination Product No
PCCP Authorized No
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.

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 18
Devices cleared under the same product code (LZH) and FDA review panel - the closest regulatory comparables to K111381.
Kangaroo Connect Enteral Feeding Pump with Kangaroo Connect Feeding Sets, Kangaroo Connect Portal
K153074 · Covidien · Jul 2016
Kangaroo Connect Enteral Feeding Pump with Kangaroo Connect Feeding Sets
K143263 · Covidien · May 2015
KANGAROO ENTERAL FEEDING SET WITH ENFIT CONNECTORS
K141479 · Covidien · Dec 2014
CLEARSTAR ENTERAL NUTRITION PUMP
K981541 · Frantz Medical Development, Ltd. · Aug 1998
ENTERALITE
K954735 · Zevex Intl., Inc. · Apr 1996
IVAC ENTERAL ADMIN. SETS, IVAC INFUSION PUMPS
K946168 · Ivac Corporation · Mar 1996