# K251980: ClaveQS™ Bag

- Pathway: 510(k) (Traditional)
- Applicant: Icu Medical, Inc.
- Decided: Mar 20, 2026 after 266 days
- Product code: KPE (Container, I.V.)
- Device class: 2
- Regulation: 21 CFR 880.5025
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K932477 (1994). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K201936: SmartSite Bag 500mL, SmartSite Bag 250 mL, SmartSite Bag 100 mL, Gilero, LLC (2021) Summary page 5.

## Indications for use
The ClaveQS™ Bag is intended for compounding and administration of parenteral solutions. Medication transfer in and out of the ClaveQS™ Bag is done using aseptic technique.

Source page: https://510kreport.com/device/K251980
Methodology: https://510kreport.com/methodology