# K082306: Powerloc Clear Safety Infusion Set

- Pathway: 510(k) (Special)
- Applicant: C.R. Bard, Inc.
- Decided: Aug 28, 2008 after 15 days
- Product code: FPA (Set, Administration, Intravascular)
- Device class: 2
- Regulation: 21 CFR 880.5440
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K001901 (2000). 21 ancestors in all.
4 later devices descend from it; 2 cite it directly.
0 of 26 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K060812: Powerport (TM)Implanted Titanium Port W/8 FR. Chronoflex Catheter-Multiple, C.R. Bard, Inc. (2006) Summary page 1.
- K051009: Huber Clear Safety Infusion Set, Now Medical Distribution, Inc. (2005) Summary page 1.

## Most influential descendants
- K111101: Norport CT-PC, Lucent Non-Coring Needel Infusion Set (2011), 2 descendants of its own
- K112713: Norfolk Medical-Sportport-Family of Ports (2011), 1 descendant of its own
- K192291: TidalPort-AP Implantable Apheresis Vascular Access Port (2020), 0 descendants of its own
- K120261: PPS PI Pressure Injectable Safety Huber Needle Without Lateral Injection Site, PPS PI Pressure Injectable Safety Huber (2012), 0 descendants of its own

## Indications for use
The PowerLoc* Clear Safety Infusion Set is an intravascular administration set with a non-coring right angle needle and manually activated needle-stick safety mechanism. The device is used to access surgically implanted vascular ports. The PowerLoc* Clear Safety Infusion Set is indicated for use in the administration of fluids and drugs, as well as blood sampling through surgically implanted vascular ports. When used with the PowerPort* device, the PowerLoc* Clear Safety Infusion Set is also indicated for power injection of contrast media into the central venous system. For power injection of contrast media, the maximum recommended infusion rate is 5 ml/s for 19 Ga. and 20 Ga. needles and 2 ml/s for 22 Ga. needles.

Source page: https://510kreport.com/device/K082306
Methodology: https://510kreport.com/methodology