# K080117: Patient Isolation Unit, Model G019-1000

- Pathway: 510(k) (Traditional)
- Applicant: Gentex Corporation
- Decided: Jan 30, 2009 after 379 days
- Product code: LGM (Chamber, Patient Isolation)
- Device class: 2
- Regulation: 21 CFR 880.5450
- Recalls of this device: none
- 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’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The Gentex Patient Isolation Unit (PIU) is a temporary, single-use, portable structure that is designed to folly contain and transport a patient and prevent particulate cross-contamination between the patient, the external environment and the caregivers. The PIU is designed to enable medical care-giving to the patient via integrated medical bulkheads interfaced with end-user supplied medical products and equipment. The PIU is intended to be used as a means to temporarily isolate a contaminated patient, outside or within patient care facilities. The PIU can also be used to transport those patients within vehicles, including aircraft, via a NATO-type or similar litter/gumey.

Source page: https://510kreport.com/device/K080117
Methodology: https://510kreport.com/methodology