# K974589: Smartvalve

- Pathway: 510(k) (Traditional)
- Applicant: Icu Medical, Inc.
- Decided: Jan 9, 1998 after 31 days
- Product code: FPA (Set, Administration, Intravascular)
- Device class: 2
- Regulation: 21 CFR 880.5440
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) McGaw Anesthesia Triple Valve Manifold: named in the summary without a submission number
- (no number) ICU Medical Stopcock with Extension Tubing: named in the summary without a submission number

## Recalls of this device
- May 12, 2026 · Class II · Z-3160-2026: Intravascular administration tubing set drip chambers may have black specks potentially due to the plastic molding process leaving discolored polyvinyl chloride (PVC) material within the drip chamber 
- Jul 6, 2020 · Class II · Z-0252-2021: Identification of a potential manufacturing defect on the internal surface of the NanoClave within specific lots of NanoClave sets, which may inhibit a proper seal with the NanoClave spike.
- Jul 6, 2020 · Class II · Z-0257-2021: Identification of a potential manufacturing defect on the internal surface of the NanoClave within specific lots of NanoClave sets, which may inhibit a proper seal with the NanoClave spike.

## Indications for use
The SmartValve is a single use, sterile, non-pyrogenic pressure activated check valve system intended for use as an accessory to Intravascular administration set. The SmartValve provides access for the administration of fluids from a container to a patient's vascular system through the administration set's needle or catheter (which is inserted into a vein or artery). The SmartValve also provides access for the withdrawal of fluids from administration set.

Source page: https://510kreport.com/device/K974589
Methodology: https://510kreport.com/methodology