Cleared Traditional

K260180 - Carecube Negative Pressure Isolation Chamber (1BY)

K260180 is an FDA 510(k) clearance for Carecube Negative Pressure Isolation Ch..., manufactured by Carecubes, Inc.. The device is a Class 2 General Hospital device with product code LGM cleared through the Traditional 510(k) pathway after a 268-day FDA review.

K260180 · Carecubes, Inc. · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Oct 2026
Decision
268d
Days
Class 2
Risk

K260180 is an FDA 510(k) clearance for the Carecube Negative Pressure Isolation Chamber (1BY). Classified as Chamber, Patient Isolation (product code LGM), Class II - Special Controls.

Submitted by Carecubes, Inc. (San Francisco, US). The FDA issued a Cleared decision on October 16, 2026 after a review of 268 days - an extended review cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5450 - the FDA general hospital device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

FDA 510(k) Submission Details - K260180

510(k) Number K260180 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 21, 2026
Decision Date October 16, 2026
Days to Decision 268 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
139d slower than avg
Panel avg: 129d · This submission: 268d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LGM Device Classification - Class 2, Special Controls

Product Code LGM Chamber, Patient Isolation
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5450
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General Hospital devices follow this clearance model.

Regulatory Consultant

Sol MedTech Compliance, LLC
Niki Spaniel

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - LGM Chamber, Patient Isolation

All 12
Devices cleared under the same product code (LGM) and FDA review panel - the closest regulatory comparables to K260180.
Carecube Negative Pressure Isolation Chamber
K231256 · Carecubes, Inc. · Jan 2024
ORCA (tm) - Operational Rescue Containment Apparatus
K163223 · Isovac Products, LLC · Nov 2017
PATIENT ISOLATION UNIT, MODEL G019-1000
K080117 · Gentex Corporation · Jan 2009
FAILSAFE - PORTABLE INFECTION CONTROL SYSTEMS
K022260 · Isolation Systems, Inc. · Aug 2002
MTB 1043 TREATMENT BOOTH
K944133 · Mark Solutions, Inc. · Sep 1995
MICROBACT 12A SYSTEM, 12B SYSTEM, AND 24E SYSTEM
K912444 · Radiometer America, Inc. · Feb 1992
K260180 · Carecube Negative Pressure Isolation Chamber (1BY)
Download PDF FDA Summary Carecubes, Inc.