# K843523: Empty Solution Transfer Container 1000

- Pathway: 510(k) (Traditional)
- Applicant: Polymer Technology Corp.
- Decided: Oct 16, 1984 after 39 days
- Product code: KPE (Container, I.V.)
- Device class: 2
- Regulation: 21 CFR 880.5025
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Recalls of this device
- Sep 13, 2017 · Class II · Z-3240-2017: The hot stamp label on the bag incorrectly states the material of the vinyl (bag) container. The bags are correctly made with PVC material, as ordered and as labeled on the inner and outer boxes.
- Jun 23, 2016 · Class II · Z-2261-2016: An issue was identified after a redesign of the auto compounding device. The compounder cannot meet the designed accuracy specification when dispensing into bags. After reviewing the initial design of

Source page: https://510kreport.com/device/K843523
Methodology: https://510kreport.com/methodology