# K231256: Carecube Negative Pressure Isolation Chamber

- Pathway: 510(k) (Traditional)
- Applicant: Carecubes, Inc.
- Decided: Jan 3, 2024 after 247 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
Longest line of descent: 2 generations back to K790657 (1979). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K052798: Capsuls, Models 2003-PUR8C, 2004-PVC8C, Isovac Products, LLC (2006) Summary page 6.

## Indications for use
The Carecube is a patient isolation unit (PIU) designed for the temporary isolation of patients within a hospital setting to prevent particulate (biological) cross-contamination between user and patient, while enclosing the contaminated patient from the external environment. Device should only be used in a hospital setting. This is for temporary housing of a patient prior to transfer to an appropriate hospital destination. Transfer to a more permanent hospital setting should occur as soon as possible. The Carecube is designed with features that enable low-moderate complexity medical interventions. This includes the following procedures: blood draw, medication administration, palpating abdomen, cardiac auscultation, and connection to IV line/monitoring cables.

Source page: https://510kreport.com/device/K231256
Methodology: https://510kreport.com/methodology