Cleared Traditional

K231256 - Carecube Negative Pressure Isolation Ch...

K231256 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 247-day FDA review.

K231256 · Carecubes, Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2024
Decision
247d
Days
Class 2
Risk

K231256 is an FDA 510(k) clearance for the Carecube Negative Pressure Isolation Chamber. 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 January 3, 2024 after a review of 247 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.

View all Carecubes, Inc. devices

FDA 510(k) Submission Details - K231256

510(k) Number K231256 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 01, 2023
Decision Date January 03, 2024
Days to Decision 247 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
118d slower than avg
Panel avg: 129d · This submission: 247d
Pathway characteristics
Predicate-based equivalence.

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. Clinical trial data may be submitted as supporting evidence to strengthen the substantial equivalence argument. Most General Hospital devices follow this clearance model.

Clinical Evidence

ClinicalTrials.gov
NCT05468723 Completed Observational Industry-sponsored

Evaluating Patient Comfort and Environmental Conditions in the Carecube Negative Pressure Isolation Chamber.1

11
Patients (actual)
1
Site
Condition studied Infectious Diseases
Eligibility All sexes · 19 Years+ · Healthy volunteers accepted
Principal investigator Andy Schnaubelt
Sponsor Carecubes, Inc. (industry)
Started 2022-05-24 → Primary completion 2022-06-18
Primary outcome
Body Temperature
Secondary outcome
Comfort
Study completed - no results published. This trial concluded in 2022 but has not posted results to ClinicalTrials.gov. Completed studies without public results are common in industry-sponsored device trials; the data may be referenced in the 510(k) Summary PDF or remain unpublished.
View full study on ClinicalTrials.gov

Regulatory Peers - LGM Chamber, Patient Isolation

Devices cleared under the same product code (LGM) and FDA review panel - the closest regulatory comparables to K231256.
MICROBACT 12A SYSTEM, 12B SYSTEM, AND 24E SYSTEM
K912444 · Radiometer America, Inc. · Feb 1992
MODEL 7-AT TREATMENT CHAMBER
K896721 · J. H. Emerson Co. · Jan 1990
INFECTIOUS DISEASE PROTECTION KIT, DISPOSABLE
K874306 · Busse Hospital Disposables, Inc. · Mar 1988
ANAGO ISOLATION MASK (#80-950)
K864116 · Anago, Inc. · Nov 1986
ISOLATION MASK I.C.S.
K831062 · American Threshold Industries, Inc. · Apr 1983
STRETCHER TRANSIT ISOLATER #122
K790657 · Vickers America Medical Corp. · Jul 1979