LGM · Chamber, Patient Isolation
General Hospital · 21 CFR 880.5450 · Class 2
Overview
| Product Code | LGM |
|---|---|
| Device Name | Chamber, Patient Isolation |
| Regulation | 21 CFR 880.5450 |
| Device Class | Class 2 |
| Review Panel | General Hospital |
| 3rd-Party Reviewable | Yes |
Identification
A patient care reverse isolation chamber is a device consisting of a roomlike enclosure designed to prevent the entry of harmful airborne material. This device protects a patient who is undergoing treatment for burns or is lacking a normal immunosuppressive defense due to therapy or congenital abnormality. The device includes fans and air filters which maintain an atmosphere of clean air at a pressure greater than the air pressure outside the enclosure.
Classification Rationale
Class II (performance standards).
Recent Cleared Devices (12 of 12)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K231256 | Carecube Negative Pressure Isolation Chamber | Carecubes, Inc. | Jan 3, 2024 | SESE |
| K163223 | ORCA (tm) - Operational Rescue Containment Apparatus | Isovac Products, LLC | Nov 2, 2017 | SESE |
| K080117 | PATIENT ISOLATION UNIT, MODEL G019-1000 | Gentex Corporation | Jan 30, 2009 | SESE |
| K022260 | FAILSAFE - PORTABLE INFECTION CONTROL SYSTEMS | Isolation Systems, Inc. | Aug 29, 2002 | SESE |
| K944133 | MTB 1043 TREATMENT BOOTH | Mark Solutions, Inc. | Sep 7, 1995 | SESE |
| K912444 | MICROBACT 12A SYSTEM, 12B SYSTEM, AND 24E SYSTEM | Radiometer America, Inc. | Feb 18, 1992 | SESE |
| K896721 | MODEL 7-AT TREATMENT CHAMBER | J. H. Emerson Co. | Jan 22, 1990 | SESE |
| K884295 | SURGICAL APPAREL, ISOLATION GOWN,MASK,CAP,SLEEVE | Saybrex Intl., Inc. | Nov 8, 1988 | SESE |
| K874306 | INFECTIOUS DISEASE PROTECTION KIT, DISPOSABLE | Busse Hospital Disposables, Inc. | Mar 22, 1988 | SESE |
| K864116 | ANAGO ISOLATION MASK (#80-950) | Anago, Inc. | Nov 25, 1986 | SESE |
| K831062 | ISOLATION MASK I.C.S. | American Threshold Industries, Inc. | Apr 13, 1983 | SESE |
| K790657 | STRETCHER TRANSIT ISOLATER #122 | Vickers America Medical Corp. | Jul 3, 1979 | SESE |
Top Applicants
- American Threshold Industries, Inc. — 1 clearance
- Anago, Inc. — 1 clearance
- Busse Hospital Disposables, Inc. — 1 clearance
- Carecubes, Inc. — 1 clearance
- Gentex Corporation — 1 clearance
