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FDA 510(k)

LifeShield Infusion Safety Software Suite

K-Number: K242117 · 2025-04-02

ApplicantIcu Medical, Inc.
Decision Date2025-04-02
Product CodePHC
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

LifeShield Infusion Safety Software Suite 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 2025-04-02 under 510(k) number K242117. The device is classified under product code PHC. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LifeShield Infusion Safety Software Suite?

LifeShield Infusion Safety Software Suite is a medical device that received FDA 510(k) clearance on 2025-04-02. The listed applicant is Icu Medical, Inc.. The 510(k) number is K242117.

When did LifeShield Infusion Safety Software Suite receive FDA 510(k) clearance?

LifeShield Infusion Safety Software Suite received FDA 510(k) clearance on 2025-04-02, under 510(k) number K242117.

Who is the listed applicant for LifeShield Infusion Safety Software Suite?

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 LifeShield Infusion Safety Software Suite?

The FDA product code for LifeShield Infusion Safety Software Suite is PHC.

Other records listing Icu Medical, Inc. as applicant

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.

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Related Devices (Code: PHC)

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.

K252130LifeShield Infusion Safety Software SuiteIcu Medical, Inc.K243062BD Intelliport System; BD Intelliport Reader (516230); BD Intelliport Sensor (516229); BD Intelliport Gateway (516232); BD Intelliport Mount (516233); BD Intelliport Charger (516231)Becton DickinsonK230665Dose IQ Safety SoftwareBaxter Healthcare CorporationK223606LifeShield™ Infusion Safety Software SuiteIcu Medical, Inc.K211124Dose IQ Safety SoftwareBaxter Healthcare CorporationK210075Vigilant Software Suite – Vigilant Master MedFresenius Kabi AG

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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