# K863606: Butterfly Non-Coring Needle Set

- Pathway: 510(k) (Traditional)
- Applicant: Cormed, Inc., Sub. C.R.Bard, Inc.
- Decided: Dec 18, 1986 after 93 days
- Product code: FMI (Needle, Hypodermic, Single Lumen)
- Device class: 2
- Regulation: 21 CFR 880.5570
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
71 later devices descend from it; 1 cites it directly.
0 of 72 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K013394: Liftloc Safety Infusion Set (2001), 70 descendants of its own
- K042234: Modification to: Liftloc Saftey Infusion Set (2004), 68 descendants of its own
- K050600: Miniloc Safety Infusion Set (2005), 67 descendants of its own
- K060812: Powerport (TM)Implanted Titanium Port W/8 FR. Chronoflex Catheter-Multiple (2006), 66 descendants of its own
- K070003: Power Injectable Implantable Infusion Port with Silicone Lumen (Attachable and Pre-Attached) (2007), 20 descendants of its own

## Recalls of this device
- Sep 23, 2003 · Not classified · Z-0098-04: Sterility of product is compromised by open seals in packaging.

Source page: https://510kreport.com/device/K863606
Methodology: https://510kreport.com/methodology