← Product Code [LGM](/productcode/LGM) · K260180

# Carecube Negative Pressure Isolation Chamber (1BY) (K260180)

_Carecubes, Inc. · LGM · Oct 16, 2026 · General Hospital · SESE_

**Canonical URL:** https://fda.innolitics.com/device/K260180

## Device Facts

- **Applicant:** Carecubes, Inc.
- **Product Code:** [LGM](/productcode/LGM.md)
- **Decision Date:** Oct 16, 2026
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 880.5450
- **Device Class:** Class 2
- **Review Panel:** General Hospital

## Regulatory Identification

A patient care reverse isolation chamber is a device consisting of a roomlike enclosure designed to prevent the entry of harmful airborne material. This device protects a patient who is undergoing treatment for burns or is lacking a normal immunosuppressive defense due to therapy or congenital abnormality. The device includes fans and air filters which maintain an atmosphere of clean air at a pressure greater than the air pressure outside the enclosure.

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**Source:** [https://fda.innolitics.com/device/K260180](https://fda.innolitics.com/device/K260180)

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