# K883582: Varidyne Model 250 Suction Drainage System

- Pathway: 510(k) (Traditional)
- Applicant: Surgidyne, Inc.
- Decided: Oct 3, 1988 after 42 days
- Product code: BTA (Pump, Portable, Aspiration (Manual Or Powered))
- Device class: 2
- Regulation: 21 CFR 878.4780
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
5 later devices descend from it; 1 cites it directly.
0 of 6 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
- K972703: Redyrob-Closed Wound Drainage System (1997), 4 descendants of its own
- K180606: SOMAVAC Device (2018), 3 descendants of its own
- K222856: SOMAVAC 100 Sustained Vacuum System (2022), 2 descendants of its own
- K231063: SOMAVAC® 100 Sustained Vacuum System (2023), 0 descendants of its own
- K223373: Enivo™ (2023), 0 descendants of its own

Source page: https://510kreport.com/device/K883582
Methodology: https://510kreport.com/methodology