# K101940: Equashield System Protective Plus

- Pathway: 510(k) (Traditional)
- Applicant: Equashield Medical, Ltd.
- Decided: Nov 19, 2010 after 130 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: 6 generations back to K883614 (1988). 13 ancestors in all.
7 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.
- K091389: Equalshield Luer Lock Connector Pair, Plastmed, Ltd. (2009) Summary page 1.

## Most influential descendants
- 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
- K251340: ProSeal™ Bag Spike with Additive Port (423370ST, 423370) (2025), 0 descendants of its own

## Indications for use
The EQUASHIELD™ System 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. The EQUASHIELD™ System has an additional Protective Plug accessory which functions as a feature that mechanically prohibits the entrance of any objects into the EQUASHIELD™ System by physically blocking and protecting the system's connector ports.

Source page: https://510kreport.com/device/K101940
Methodology: https://510kreport.com/methodology