# K022260: Failsafe - Portable Infection Control Systems

- Pathway: 510(k) (Traditional)
- Applicant: Isolation Systems, Inc.
- Decided: Aug 29, 2002 after 62 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
For Transporting and Isolating a TB patient or a suspected TB patient

Source page: https://510kreport.com/device/K022260
Methodology: https://510kreport.com/methodology