# K091389: Equalshield Luer Lock Connector Pair

- Pathway: 510(k) (Special)
- Applicant: Plastmed, Ltd.
- Decided: Oct 22, 2009 after 164 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: 5 generations back to K883614 (1988). 12 ancestors in all.
8 later devices descend from it; 1 cites 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)
- K083152: Equashield System, Plastmed, Ltd. (2009) Summary page 1.

## Most influential descendants
- 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
- K241988: ProSeal™ Closed System Bag Access (2024), 2 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/K091389
Methodology: https://510kreport.com/methodology