# K831531: Surgical Isolation Barrier System

- Pathway: 510(k) (Traditional)
- Applicant: Lone Star Medical Products, Inc.
- Decided: Jun 5, 1984 after 391 days
- 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
- K092801: Abs Blower, Abs Nozzle, Model 1001 (2011), 4 descendants of its own
- K123006: Air Barrier System (Abs) (2013), 3 descendants of its own
- K153498: Operio (2016), 2 descendants of its own
- K173349: Operio (2017), 0 descendants of its own
- K163455: SurgiCube (2017), 0 descendants of its own

Source page: https://510kreport.com/device/K831531
Methodology: https://510kreport.com/methodology