# K991404: Platypus AV Fistula Needle Protector (Avfnp)

- Pathway: 510(k) (Traditional)
- Applicant: Itl Corporation Pty, Ltd.
- Decided: May 14, 1999 after 22 days
- Product code: FMI (Needle, Hypodermic, Single Lumen)
- Device class: 2
- Regulation: 21 CFR 880.5570
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K932074 (1994). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K932074: Medisystems Apheresis Needle with Guard, Medisystems Corp. (1994) Summary page 1.

## Cited in the summary but kept off the family tree
- K980008: Bloodpack Needle Protector (BNP). The summary prints BK980008, a CBER number, which our reading took as K980008, which is not in FDA’s 510(k) list. Kept off the family tree. Summary page 1.

## Indications for use
The AV Fistula Needle Protector (AVFNP) is intended for use in the prevention of accidental needle stick injuries upon completion of hemodialysis and apheresis procedures.

Source page: https://510kreport.com/device/K991404
Methodology: https://510kreport.com/methodology