Cleared Traditional

K051828 - NIPRO SUREFUSER AMBULATORY INFUSION PUMP

K051828 is an FDA 510(k) clearance for NIPRO SUREFUSER AMBULATORY INFUSION PUMP, manufactured by Nipro Medical Corporation. The device is a Class 2 General Hospital device with product code MEB cleared through the Traditional 510(k) pathway after a 162-day FDA review.

K051828 · Nipro Medical Corporation · General Hospital
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Optimized for regulatory review, auditing and printing
Dec 2005
Decision
162d
Days
Class 2
Risk

K051828 is an FDA 510(k) clearance for the NIPRO SUREFUSER AMBULATORY INFUSION PUMP. Classified as Pump, Infusion, Elastomeric (product code MEB), Class II - Special Controls.

Submitted by Nipro Medical Corporation (Lexington, US). The FDA issued a Cleared decision on December 15, 2005 after a review of 162 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 Nipro Medical Corporation devices

FDA 510(k) Submission Details - K051828

510(k) Number K051828 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 06, 2005
Decision Date December 15, 2005
Days to Decision 162 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
33d slower than avg
Panel avg: 129d · This submission: 162d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MEB Device Classification - Class 2, Special Controls

Product Code MEB Pump, Infusion, Elastomeric
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 - MEB Pump, Infusion, Elastomeric

All 60
Devices cleared under the same product code (MEB) and FDA review panel - the closest regulatory comparables to K051828.
ON-Q, PAINBUSTER, C-BLOC, SELECT-A-FLOW, ONDEMAND, HOMEPUMP, ECLIPSE, C-SERIES, ONE-STEP KVO, EASYPUMP
K063530 · I-Flow Corp. · Jan 2007
INFUSOR SMALL VOLUME ELASTOMERIC INFUSION DEVICES
K062457 · Baxter Healthcare Corporation · Sep 2006
SEMPERFLO INFUSION SYSTEM
K052999 · Ethicon, Inc. · Mar 2006
MPS ACACIA MEDFLO ELASTOMERIC PUMP
K052451 · Mps Acacia · Dec 2005
I-FLOW ELASTOMERIC PUMP (ON-Q, PAINBUSTER, C-BLOCK, HOMEPUMP, EASYPUMP)
K052117 · I-Flow Corp. · Sep 2005
SYMBIOS DISPOSABLE INFUSION PUMP KIT
K051474 · Symbios Medical Products, LLC · Jul 2005