510(k) clearance

Carecube Negative Pressure Isolation Chamber (1BY)

FDA 510(k) source

510(k) number

K260180

Applicant

Carecubes, Inc.

Decision date

Oct 16, 2026

Date received

Jan 21, 2026

Decision

Substantially Equivalent

Clearance type

Traditional

Product code

LGM

Device type

Chamber, Patient Isolation

Device class

Class II

Regulation

21 CFR 880.5450

Advisory committee

General Hospital

Statement or summary

Summary

Third party

N

Location

San Francisco, CA, US