# K070532: Spiros

- Pathway: 510(k) (Special)
- Applicant: Icu Medical, Inc.
- Decided: Mar 20, 2007 after 22 days
- Product code: FPA (Set, Administration, Intravascular)
- Device class: 2
- Regulation: 21 CFR 880.5440
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
16 later devices descend from it; 4 cite it directly.
2 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Most influential descendants
- K082806: Spinning Spiros, Model CH-2000 (2009), 12 descendants of its own
- K081361: Chemoclave Cytotoxic Medication Preparation and Delivery System, Model, CH-XXXX (2008), 12 descendants of its own
- K131549: Chemolock, Chemolock Port (2013), 10 descendants of its own
- K141448: Tevadaptor Closed Drug Reconstitution and Transfer System (2015), 9 descendants of its own
- K192866: Chemfort CSTD (2020), 3 descendants of its own

## Recalls of this device
- Aug 31, 2020 · Class II · Z-0699-2021: Potential for spinning versions of male luers to exhibit leaks due to a molding defect. Fluid leakage may potentially cause delay of infusion, contamination of the fluid path, exposure to hazardous me

## Indications for use
The SpirosTM is a single use, sterile, non-pvrogenic, swab-able, bi-directional valve device intended for use as an accessory to Intravascular Administration Set. The SpirosTM provides access of the administration of fluids from a container to a patient's vascular system through the administration needle or catheter (which is inserted into the vein or artery).

Source page: https://510kreport.com/device/K070532
Methodology: https://510kreport.com/methodology