Flowmedica Benephit Infusion Systems

510(k) K082163

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

6 closed

Documents

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

Region	Authorization	Number	Date	Status
United States	FDA 510(k)SESE Substantially Equivalent · Traditional	NumberK082163	Date29 Oct 2008Cleared	StatusActive

6 recalls · FDA

3 recalls, same reason
- Terminated Z-1114-2012 FDA Not yet classified initiated 6 Feb 2012
- Terminated Z-1112-2012 FDA Not yet classified initiated 6 Feb 2012
- Terminated Z-1113-2012 FDA Not yet classified initiated 6 Feb 2012
The Benephit CV Infusion System contains a Sheath Y Connector that has the potential to develop cracks.
- Terminated Z-0509-2012 FDA Unclassified (pre-2012) initiated 5 Dec 2011
The Benephit XT Infusion System may contain hairline cracks in the sheath hub.
2 recalls, same reason
- Terminated Z-1734-2010 FDA Unclassified (pre-2012) initiated 30 Apr 2010
- Terminated Z-1733-2010 FDA Unclassified (pre-2012) initiated 30 Apr 2010
Benephit Infusion Catheters may exhibit a hole or tear in the primary sterile barrier packaging. The product is intended to be sterile. Breaches in the sterile packaging may result in non-sterile product, which could potentially cause a patient infection which is a serious medical condition.

1 jurisdiction

United States — FDA 510(k) Active

510(k)