Cleared Traditional

K181360 - ON-Q* Pump with Bolus

K181360 is an FDA 510(k) clearance for ON-Q* Pump with Bolus, manufactured by Halyard Health. The device is a Class 2 General Hospital device with product code MEB cleared through the Traditional 510(k) pathway after a 304-day FDA review.

K181360 · Halyard Health · General Hospital
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Mar 2019
Decision
304d
Days
Class 2
Risk

K181360 is an FDA 510(k) clearance for the ON-Q* Pump with Bolus. Classified as Pump, Infusion, Elastomeric (product code MEB), Class II - Special Controls.

Submitted by Halyard Health (Irvine, US). The FDA issued a Cleared decision on March 22, 2019 after a review of 304 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Halyard Health devices

FDA 510(k) Submission Details - K181360

510(k) Number K181360 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 22, 2018
Decision Date March 22, 2019
Days to Decision 304 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
175d slower than avg
Panel avg: 129d · This submission: 304d
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 59
Devices cleared under the same product code (MEB) and FDA review panel - the closest regulatory comparables to K181360.
SMARTeZ™ Elastomeric Infusion Pump (RS series)
K250234 · Epic Medical Pte. , Ltd. · Apr 2026
InfuLife
K240624 · First Medical Source, LLC · Nov 2024
SMARTeZ™ Elastomeric Infusion Pump (498111, 498121, 498131, 498141)
K242152 · Epic Medical Pte. , Ltd. · Oct 2024
SMARTez elastomeric infusion pump
K151650 · Epic Medical Pte. , Ltd. · Apr 2016
ON-Q PAINBUSTER, ON-Q C-BLOC, HOMEPUMP ECLIPSE, HOMEPUMP C-SERIES
K131249 · I-Flow, LLC · Feb 2014
MULTIBOLUS II DISPOSABLE PAIN MANAGEMENT SYSTEM
K131247 · Mfs - Medical Flow Systems, Ltd. · Aug 2013