LGM
12 FDA 510(k) clearances · Product code
154 daysmedian time to decision
379 days90th percentile
12clearances measured
FDA profile
- Official device name
- Chamber, Patient Isolation
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 880.5450
- Medical specialty
- General Hospital
- Flags
- Third-party review eligible
- Adverse events (MAUDE)
- 1997: 2
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| Carecube Negative Pressure Isolation Chamber (K231256) | Carecubes, Inc. | 2024-01-03 |
| ORCA (tm) - Operational Rescue Containment Apparatus (K163223) | Isovac Products, LLC | 2017-11-02 |
| PATIENT ISOLATION UNIT, MODEL G019-1000 (K080117) | Gentex Corporation | 2009-01-30 |
| FAILSAFE - PORTABLE INFECTION CONTROL SYSTEMS (K022260) | Isolation Systems, Inc. | 2002-08-29 |
| MTB 1043 TREATMENT BOOTH (K944133) | Mark Solutions, Inc. | 1995-09-07 |
| MICROBACT 12A SYSTEM, 12B SYSTEM, AND 24E SYSTEM (K912444) | Radiometer America, Inc. | 1992-02-18 |
| MODEL 7-AT TREATMENT CHAMBER (K896721) | J. H. Emerson Co. | 1990-01-22 |
| SURGICAL APPAREL, ISOLATION GOWN,MASK,CAP,SLEEVE (K884295) | Saybrex Intl., Inc. | 1988-11-08 |
| INFECTIOUS DISEASE PROTECTION KIT, DISPOSABLE (K874306) | Busse Hospital Disposables, Inc. | 1988-03-22 |
| ANAGO ISOLATION MASK (#80-950) (K864116) | Anago, Inc. | 1986-11-25 |
| ISOLATION MASK I.C.S. (K831062) | American Threshold Industries, Inc. | 1983-04-13 |
| STRETCHER TRANSIT ISOLATER #122 (K790657) | Vickers America Medical Corp. | 1979-07-03 |
Track LGM automatically
Every clearance here is in the API, with alerts when new ones post.