LGM · Class II · 21 CFR 880.5450

FDA Product Code LGM: Chamber, Patient Isolation

Leading manufacturers include J. H. Emerson Co., Radiometer America, Inc. and Carecubes, Inc..

12
Total
12
Cleared
170d
Avg days
1979
Since
Declining activity - 0 submissions in the last 2 years vs 1 in the prior period

FDA 510(k) Cleared Chamber, Patient Isolation Devices (Product Code LGM)

12 devices
1–12 of 12
Cleared Jan 03, 2024
Carecube Negative Pressure Isolation Chamber
K231256
Carecubes, Inc.
General Hospital · 247d
Cleared Feb 18, 1992
MICROBACT 12A SYSTEM, 12B SYSTEM, AND 24E SYSTEM
K912444
Radiometer America, Inc.
General Hospital · 260d
Cleared Jan 22, 1990
MODEL 7-AT TREATMENT CHAMBER
K896721
J. H. Emerson Co.
General Hospital · 55d
Cleared Mar 22, 1988
INFECTIOUS DISEASE PROTECTION KIT, DISPOSABLE
K874306
Busse Hospital Disposables, Inc.
General Hospital · 154d
Cleared Nov 25, 1986
ANAGO ISOLATION MASK (#80-950)
K864116
Anago, Inc.
General Hospital · 35d
Cleared Apr 13, 1983
ISOLATION MASK I.C.S.
K831062
American Threshold Industries, Inc.
General Hospital · 5d
Cleared Jul 03, 1979
STRETCHER TRANSIT ISOLATER #122
K790657
Vickers America Medical Corp.
General Hospital · 89d

About Product Code LGM - Regulatory Context

510(k) Submission Activity

12 total 510(k) submissions under product code LGM since 1979, with 12 receiving FDA clearance (average review time: 170 days).

Submission volume has declined in recent years - 0 submissions in the last 24 months compared to 1 in the prior period.