Carecube Negative Pressure Isolation Chamber (1BY)— 510(k) K260180

Name: FDA 510(k) clearance K260180
Creator: U.S. Food and Drug Administration
Published: 2026-10-16

Substantially Equivalent

Carecubes, Inc.

FDA 510(k) clearance K260180 for Carecube Negative Pressure Isolation Chamber (1BY), Substantially Equivalent on 2026-10-16. Applicant: Carecubes, Inc.. Device class: 2.

Clearance details

Applicant: Carecubes, Inc.
Product code: Product code LGM
Device class: Class 2
Regulation: 21 CFR 880.5450
Advisory panel: General Hospital
Date received: 2026-01-21
Decision date: 2026-10-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Francisco, CA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code LGM

view all

K231256 — Carecube Negative Pressure Isolation Chamber2024-01-03
K163223 — ORCA (tm) - Operational Rescue Containment Apparatus2017-11-02
K080117 — PATIENT ISOLATION UNIT, MODEL G019-10002009-01-30
K022260 — FAILSAFE - PORTABLE INFECTION CONTROL SYSTEMS2002-08-29
K944133 — MTB 1043 TREATMENT BOOTH1995-09-07

Data sourced from openFDA. This site is unofficial and independent of the FDA.