Regulatory status

as of registry sync 22 Oct 2026

Region	Authorization	Number	Date	Status
United States	FDA 510(k)SESE from GUDID Substantially Equivalent · Traditional	NumberK171996	Date23 Oct 2017Decided	StatusActive
United States	GUDID listing	Number00690103002379 UDI-DI	Date3 Sep 2016Listed	StatusListed GUDID: in commercial distribution
United States	FDA 510(k)SESE from GUDID Substantially Equivalent · Traditional	NumberK142749	Date18 Jan 2015Decided	StatusActive

Recalls

11 recalls · 2 ongoing · FDA

2 recalls, same reason
- Ongoing Z-0414-2024 FDA Class II initiated 4 Oct 2023 on shared 510(k) K142749
- Ongoing Z-0413-2024 FDA Class II initiated 4 Oct 2023 on shared 510(k) K142749
Their is the potential for flushing difficulties during setup of the pressure monitoring kit with pressure transducer.
8 recalls, same reason
- Terminated Z-1961-2021 FDA Class II initiated 26 May 2021
- Terminated Z-1966-2021 FDA Class II initiated 26 May 2021
- Terminated Z-1962-2021 FDA Class II initiated 26 May 2021
- Terminated Z-1963-2021 FDA Class II initiated 26 May 2021
- Terminated Z-1965-2021 FDA Class II initiated 26 May 2021
- Terminated Z-1964-2021 FDA Class II initiated 26 May 2021
- Terminated Z-1959-2021 FDA Class II initiated 26 May 2021
- Terminated Z-1960-2021 FDA Class II initiated 26 May 2021
There is a potential that the pressure tubing may detach from the blood sampling system
- Terminated Z-2776-2015 FDA Class II initiated 31 Jul 2015
Flow restriction issues in a trifurcated IV set included in the pressure transducer kits. A restriction of the flow of IV fluid would result in either an inability to prime the system before use or difficulty in flushing the line after a blood draw.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

1 jurisdiction

United States — FDA 510(k) Active

GUDID

Show all (12)

Show all (12)