# K082806: Spinning Spiros, Model CH-2000

- Pathway: 510(k) (Special)
- Applicant: Icu Medical, Inc.
- Decided: Apr 6, 2009 after 194 days
- Product code: FPA (Set, Administration, Intravascular)
- Device class: 2
- Regulation: 21 CFR 880.5440
- Recalls of this device: 5 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K070532 (2007). 1 ancestor in all.
12 later devices descend from it; 2 cite it directly.
1 of 14 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K070532: Spiros, Icu Medical, Inc. (2007) Summary page 1.

## Most influential descendants
- 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
- K201422: Arisure Closed System Drug Transfer Device (CSTD) (2021), 1 descendant of its own
- K180489: TEVADAPTOR Closed Drug Reconstitution and Transfer System (2018), 1 descendant of its own

## Recalls of this device
- Aug 1, 2022 · Class II · Z-1723-2022: Due to a manufacturing defect which results in a visible gap between the connector's top and bottom housing.
- Mar 16, 2021 · Class II · Z-1567-2021: Due to molding defect, there is a potential that certain lots of spinning and non-spinning Sprios male luers may exhibit small amounts of leakage in the inactivated position.
- Mar 16, 2021 · Class II · Z-1568-2021: Due to molding defect, there is a potential that certain lots of spinning and non-spinning Sprios male luers may exhibit small amounts of leakage in the inactivated position.
- Mar 16, 2021 · Class II · Z-1569-2021: Due to molding defect, there is a potential that certain lots of spinning and non-spinning Sprios male luers may exhibit small amounts of leakage in the inactivated position.
- Aug 31, 2020 · Class II · Z-0702-2021: 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 Spiros is a single use, sterile, non-pyrogenic, swab-able, bidirectional valve device intended for use as an accessory to an Intravascular Administration Set. The Spiros provides access for the administration needle or catheter (which is inserted into the vein or artery).

Source page: https://510kreport.com/device/K082806
Methodology: https://510kreport.com/methodology