# K201936: SmartSite Bag 500mL, SmartSite Bag 250 mL, SmartSite Bag 100 mL

- Pathway: 510(k) (Traditional)
- Applicant: Gilero, LLC
- Decided: May 6, 2021 after 297 days
- Product code: KPE (Container, I.V.)
- Device class: 2
- Regulation: 21 CFR 880.5025
- 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 K932477 (1994). 6 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K181393: Empty Eva Bag, models FVM0134BP, FVM0135BP, FVM0136BP, FVM0137BP, FVM0138BP, FVM0139BP, FVM0140BP, FVM0141BP, Valmed S.R.L. (2019) Summary page 4.

## Most influential descendants
- K251980: ClaveQS™ Bag (2026), 0 descendants of its own
- K250459: DMRX 100ml Empty Container Solution; DMRX 250ml Empty Container Solution; DMRX 500ml Empty Container Solution; DMRX 1000ml Empty Container Solution (2025), 0 descendants of its own

## Indications for use
The SmartSite Bag is an empty container used for administration of intravenous solutions to the patient using an intravascular administration set. Medication transfer in and out of the container is done using aseptic technique.

Source page: https://510kreport.com/device/K201936
Methodology: https://510kreport.com/methodology