# K811269: Glass Vials

- Pathway: 510(k) (Traditional)
- Applicant: Medi-Plast Intl., Inc.
- Decided: Jun 16, 1981 after 42 days
- Product code: KPE (Container, I.V.)
- Device class: 2
- Regulation: 21 CFR 880.5025
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
2 later devices descend from it; 1 cites it directly.
0 of 3 devices 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.

## Most influential descendants
- K972117: Msi Bottleflow, Transflow, Vialflow (1997), 1 descendant of its own
- K092246: Nipro Needleless Transfer Device, Models: M285503 and M285505 (2009), 0 descendants of its own

## Recalls of this device
- Jun 3, 2024 · Class II · Z-2642-2024: During sterile barrier testing performed on the decanter product line, the samples were identified to have pin holes and tears in the packaging film.

Source page: https://510kreport.com/device/K811269
Methodology: https://510kreport.com/methodology