# K972703: Redyrob-Closed Wound Drainage System

- Pathway: 510(k) (Traditional)
- Applicant: B.Braun Medical, Inc.
- Decided: Oct 1, 1997 after 75 days
- Product code: GCY (Apparatus, Suction, Single Patient Use, Portable, Nonpowered)
- Device class: 1
- Regulation: 21 CFR 878.4680
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K883582 (1988). 1 ancestor in all.
4 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)
- K883582: Varidyne Model 250 Suction Drainage System, Surgidyne, Inc. (1988) Summary page 1.

## Most influential descendants
- 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

## Indications for use
REDYROB® is a vacuum source/waste container utilized for postoperative wound drainage.

Source page: https://510kreport.com/device/K972703
Methodology: https://510kreport.com/methodology