# K083152: Equashield System

- Pathway: 510(k) (Traditional)
- Applicant: Plastmed, Ltd.
- Decided: Feb 2, 2009 after 101 days
- Product code: LHI (Set, I.V. Fluid Transfer)
- 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: 4 generations back to K883614 (1988). 11 ancestors in all.
9 later devices descend from it; 2 cite it directly.
0 of 21 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K972527: Phaseal, System for Sealed Handling of Chemotherapeutic Agents, Quality System Consulting (1997) Summary page 1.
- K051669: Tevadaptor Closed Drug Reconstitution and Transfer System, Migada Plant (2005) Summary page 1.
- K071108: Texium Syringe, Cardinal Health, Alaris Products (2007) Summary page 1.

## Most influential descendants
- K091389: Equalshield Luer Lock Connector Pair (2009), 8 descendants of its own
- K101940: Equashield System Protective Plus (2010), 7 descendants of its own
- K132899: Equashield Closed System Drug Transfer Device (CSTD) (2014), 6 descendants of its own
- K170706: Equashield Closed System drug Transfer Device (CSTD) (2017), 5 descendants of its own
- K201460: Closed System Transfer Device (2022), 3 descendants of its own

## Indications for use
The EQUASHIELD TM Drug Reconstitution and Transfer System is a contained system to be used by pharmacists or other healthcare professionals to prepare drugs, including cytotoxic drugs, for intravenous infusion or injection

Source page: https://510kreport.com/device/K083152
Methodology: https://510kreport.com/methodology