# K220114: PowerPAK Syringe

- Pathway: 510(k) (Traditional)
- Applicant: Vault Paragon Group, Inc.
- Decided: Jan 25, 2023 after 376 days
- Product code: MEG (Syringe, Antistick)
- Device class: 2
- Regulation: 21 CFR 880.5860
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K980069 (1998). 4 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K023752: BD Integra Syringe, Bd (2003) Summary page 4.

## Most influential descendants
- K250847: VaporShield (2025), 0 descendants of its own

## Indications for use
The PowerPAK™ Syringe is indicated for general medical use in healthcare facilities by medical professionals for pediatric and adult population patients for aspiration and injection of fluids. Phlebotomy is not an intended use of this device. The PowerPAK™ Syringe is a 3mL syringe with a permanently attached needle system. Routes of Administration include subcutaneous, intradermal and intramuscular. Intravenous and Intraperitoneal are not intended uses of this device. The needle system contains an internal mechanism that retracts the needle inside the syringe after activation. Upon retraction, the needle is fully contained inside the syringe preventing reuse of the needle and accidental needlesticks during normal handling and disposal.

Source page: https://510kreport.com/device/K220114
Methodology: https://510kreport.com/methodology