DeviceClearance

ClaveQS Bag— 510(k) K251980

Substantially Equivalent

Icu Medical, Inc.

FDA 510(k) clearance K251980 for ClaveQS Bag, Substantially Equivalent on 2026-03-20. Applicant: Icu Medical, Inc.. Device class: 2.

Summary

Icu Medical's ClaveQS Bag is filed under KPE, I.V. containers. The record doesn't list bag volumes or model numbers.

Class II, 21 CFR 880.5025. It was a Traditional 510(k), and General Hospital is both the classification panel and the review panel.

Icu Medical filed from San Clemente, California. The decision came 266 calendar days after FDA received it (June 27, 2025 to March 20, 2026).

Clearance details

Applicant
Icu Medical, Inc.
Product code
Product code KPE
Device class
Class 2
Regulation
21 CFR 880.5025
Advisory panel
General Hospital
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
San Clemente, CA, US
Download summary PDFView on FDA.gov ↗

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Adverse events under product code KPE

product code KPE
Malfunction
1,000
Other
1
Total
1,001

Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.