Chamber, Patient Isolation
A patient isolation chamber is a device used to enclose a patient within a controlled, filtered-air environment that protects severely immunocompromised patients from environmental pathogens, or conversely, protects healthcare personnel and the environment from infectious patients. The device is FDA Class 2, indicating moderate risk and requiring 510(k) premarket clearance. It carries product code LGM and is regulated under 21 CFR 880.5450 within the General Hospital specialty. This device is eligible for third-party review.
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Basic Information
- Product Code
- LGM
- Device Class
- FDA class 2
- Regulation Number
- 880.5450
- Medical Specialty
- General Hospital
- Review Panel
- HO
- Submission Type
- 1
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 12 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K231256 | Carecube Negative Pressure Isolation Chamber | Jan 03, 2024 | Substantially Equivalent | Carecubes, Inc. |
| K163223 | ORCA (tm) - Operational Rescue Containment Apparatus | Nov 02, 2017 | Substantially Equivalent | Isovac Products, LLC |
| K080117 | PATIENT ISOLATION UNIT, MODEL G019-1000 | Jan 30, 2009 | Substantially Equivalent | Gentex Corporation |
| K022260 | FAILSAFE - PORTABLE INFECTION CONTROL SYSTEMS | Aug 29, 2002 | Substantially Equivalent | Isolation Systems, Inc. |
| K944133 | MTB 1043 TREATMENT BOOTH | Sep 07, 1995 | Substantially Equivalent | Mark Solutions, Inc. |
| K912444 | MICROBACT 12A SYSTEM, 12B SYSTEM, AND 24E SYSTEM | Feb 18, 1992 | Substantially Equivalent | Radiometer America, Inc. |
| K896721 | MODEL 7-AT TREATMENT CHAMBER | Jan 22, 1990 | Substantially Equivalent | J. H. Emerson Co. |
| K884295 | SURGICAL APPAREL, ISOLATION GOWN,MASK,CAP,SLEEVE | Nov 08, 1988 | Substantially Equivalent | Saybrex Intl., Inc. |
| K874306 | INFECTIOUS DISEASE PROTECTION KIT, DISPOSABLE | Mar 22, 1988 | Substantially Equivalent | Busse Hospital Disposables, Inc. |
| K864116 | ANAGO ISOLATION MASK (#80-950) | Nov 25, 1986 | Substantially Equivalent | Anago, Inc. |
| K831062 | ISOLATION MASK I.C.S. | Apr 13, 1983 | Substantially Equivalent | American Threshold Industries, Inc. |
| K790657 | STRETCHER TRANSIT ISOLATER #122 | Jul 03, 1979 | Substantially Equivalent | Vickers America Medical Corp. |
FEI Numbers
This FDA classification entry is associated with 6 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 6 registration numbers. Click on an entry to view related FDA registrations.