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FDA 510(k)

Plum Solo™ Precision IV Pump

K-Number: K242114 · 2025-04-02

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

Device Summary

Plum Solo™ Precision IV Pump 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 K242114. The device is classified under product code FRN. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Plum Solo™ Precision IV Pump?

Plum Solo™ Precision IV Pump 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 K242114.

When did Plum Solo™ Precision IV Pump receive FDA 510(k) clearance?

Plum Solo™ Precision IV Pump received FDA 510(k) clearance on 2025-04-02, under 510(k) number K242114.

Who is the listed applicant for Plum Solo™ Precision IV Pump?

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 Plum Solo™ Precision IV Pump?

The FDA product code for Plum Solo™ Precision IV Pump is FRN.

Other records listing Icu Medical, Inc. as applicant

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Related Devices (Code: FRN)

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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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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