# K932188: Safeset Reservoir

- Pathway: 510(k) (Traditional)
- Applicant: Abbott Laboratories
- Decided: Oct 25, 1993 after 172 days
- Product code: KRA (Catheter, Continuous Flush)
- Device class: 2
- Regulation: 21 CFR 870.1210
- Recalls of this device: 16 (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. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Recalls of this device
- Aug 10, 2016 · Class II · Z-2828-2016: ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers.
- Aug 10, 2016 · Class II · Z-2817-2016: ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers.
- Aug 10, 2016 · Class II · Z-2820-2016: ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers.
- Aug 10, 2016 · Class II · Z-2813-2016: ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers.
- Aug 10, 2016 · Class II · Z-2818-2016: ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers.
- Aug 10, 2016 · Class II · Z-2823-2016: ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers.
- Aug 10, 2016 · Class II · Z-2821-2016: ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers.
- Aug 10, 2016 · Class II · Z-2822-2016: ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers.
- Aug 10, 2016 · Class II · Z-2807-2016: ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers.
- Aug 10, 2016 · Class II · Z-2825-2016: ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers.
- Aug 10, 2016 · Class II · Z-2811-2016: ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers.
- Aug 10, 2016 · Class II · Z-2815-2016: ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers.
- Nov 2, 2004 · Not classified · Z-0618-05: Syringes could possibly allow air to enter the patient's vascular system.
- Nov 2, 2004 · Not classified · Z-0619-05: Syringes could possibly allow air to enter the patient's vascular system.
- Nov 2, 2004 · Not classified · Z-0620-05: Syringes could possibly allow air to enter the patient's vascular system.
- Nov 2, 2004 · Not classified · Z-0617-05: Syringes could possibly allow air to enter the patient's vascular system.

Source page: https://510kreport.com/device/K932188
Methodology: https://510kreport.com/methodology