# K833586: TLS Bulb Drainage System

- Pathway: 510(k) (Traditional)
- Applicant: Porex Medical
- Decided: Jan 30, 1984 after 110 days
- Product code: GCY (Apparatus, Suction, Single Patient Use, Portable, Nonpowered)
- Device class: 1
- Regulation: 21 CFR 878.4680
- 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
- Jan 3, 2017 · Class II · Z-1150-2017: An incorrect sterility status on the label, non-sterile products labeled as sterile
- Jan 3, 2017 · Class II · Z-1149-2017: An incorrect sterility status on the label, non-sterile products labeled as sterile

Source page: https://510kreport.com/device/K833586
Methodology: https://510kreport.com/methodology