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FDA 510(k)

ClaveQS™ Bag

K-Number: K251980 · 2026-03-20

ApplicantIcu Medical, Inc.
Decision Date2026-03-20
Product CodeKPE
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

ClaveQS™ Bag is the device name listed in this FDA 510(k) record. The listed applicant is Icu Medical, Inc.. It received FDA 510(k) clearance on 2026-03-20 under 510(k) number K251980. The device is classified under product code KPE. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ClaveQS™ Bag?

ClaveQS™ Bag is a medical device that received FDA 510(k) clearance on 2026-03-20. The listed applicant is Icu Medical, Inc.. The 510(k) number is K251980.

When did ClaveQS™ Bag receive FDA 510(k) clearance?

ClaveQS™ Bag received FDA 510(k) clearance on 2026-03-20, under 510(k) number K251980.

Who is the listed applicant for ClaveQS™ Bag?

The FDA 510(k) record lists Icu Medical, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ClaveQS™ Bag?

The FDA product code for ClaveQS™ Bag is KPE.

Other records listing Icu Medical, Inc. as applicant

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Related Devices (Code: KPE)

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.

K252079Disposable Infusion Bag for Parenteral NutritionBeijing L&Z Medical Technology Development Co., Ltd.K251139KabiHelp® Uno; KabiHelp® Advance plusFresenius Kabi AGK252094eZSURE™ Empty Fluid ContainerEpic Medical Pte. , Ltd.K250459DMRX 100ml Empty Container Solution; DMRX 250ml Empty Container Solution; DMRX 500ml Empty Container Solution; DMRX 1000ml Empty Container SolutionTechnoflex Sas.K241442eZSURE™ Empty Fluid Container with ProSeal™ Injection SiteEpic Medical Pte. , Ltd.K223674eZSURE™ Empty Fluid Container (models 426030, 426040, 426110)Epic 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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