# K063631: Polyperf / Polyperf Safe

- Pathway: 510(k) (Traditional)
- Applicant: Laboratoires Perouse
- Decided: Oct 5, 2007 after 303 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: 1 generation back to K896346 (1990). 2 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K021999: Gripper Plus Needle, Deltec, Inc. (2002) Summary page 1.
- K896346: Gripper Port-a-Cath Needle with Stopcock, Pharmacia Deltec, Inc. (1990) Summary page 1.

## Most influential descendants
- 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
POLYPERF® / POLYPERF® Safe connecting lines are indicated for the administration into or withdrawal of fluids from implanted ports. POLYPERF® Safe is designed to help protect against exposure to blood caused by "accidental needle stick injuries."

Source page: https://510kreport.com/device/K063631
Methodology: https://510kreport.com/methodology