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FDA 510(k)

ON-Q* Pump with Bolus

K-Number: K181360 · 2019-03-22

ApplicantHalyard Health
Decision Date2019-03-22
Product CodeMEB
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

ON-Q* Pump with Bolus is the device name listed in this FDA 510(k) record. The listed applicant is Halyard Health. It received FDA 510(k) clearance on 2019-03-22 under 510(k) number K181360. The device is classified under product code MEB. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ON-Q* Pump with Bolus?

ON-Q* Pump with Bolus is a medical device that received FDA 510(k) clearance on 2019-03-22. The listed applicant is Halyard Health. The 510(k) number is K181360.

When did ON-Q* Pump with Bolus receive FDA 510(k) clearance?

ON-Q* Pump with Bolus received FDA 510(k) clearance on 2019-03-22, under 510(k) number K181360.

Who is the listed applicant for ON-Q* Pump with Bolus?

The FDA 510(k) record lists Halyard Health as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ON-Q* Pump with Bolus?

The FDA product code for ON-Q* Pump with Bolus is MEB.

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Related Devices (Code: MEB)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K250234SMARTeZ™ Elastomeric Infusion Pump (RS series)Epic Medical Pte. , Ltd.K240624InfuLifeFirst Medical Source, LLCK242152SMARTeZ™ Elastomeric Infusion Pump (498111, 498121, 498131, 498141)Epic Medical Pte. , Ltd.K151650SMARTez elastomeric infusion pumpEpic Medical Pte. , Ltd.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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