FDA product code LGM: Chamber, Patient Isolation
LGM is the FDA product code for chamber, patient isolation. It is a Class II device, regulated under 21 CFR 880.5450 and reviewed by the General Hospital panel. FDA has cleared 12 510(k) submissions under LGM, 1 in the last five years, from 12 different applicants. The average 510(k) review took 170 days (median 122); 247 days on average over the last three years. FDA has posted 1 recall for LGM devices.
Classification
| Field | Value |
|---|---|
| Device name | Chamber, Patient Isolation |
| Device class | Class II |
| Regulation | 21 CFR 880.5450 |
| Review panel | HO — General Hospital |
| Medical specialty | General Hospital |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
510(k) clearances per year for LGM
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 1 | 351 |
| 2024 | 1 | 247 |
Compare with all 510(k) review times · Search every LGM clearance
Top LGM applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Carecubes, Inc. | 1 | 2024-01-03 |
| Isovac Products, LLC | 1 | 2017-11-02 |
| Gentex Corporation | 1 | 2009-01-30 |
| Isolation Systems, Inc. | 1 | 2002-08-29 |
| Mark Solutions, Inc. | 1 | 1995-09-07 |
7 more applicants have LGM clearances. See the full list in Caduvo.
Most recent LGM clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K231256 | Carecubes, Inc. | Carecube Negative Pressure Isolation Chamber | 2024-01-03 | 247 |
| K163223 | Isovac Products, LLC | ORCA (tm) - Operational Rescue Containment Apparatus | 2017-11-02 | 351 |
| K080117 | Gentex Corporation | PATIENT ISOLATION UNIT, MODEL G019-1000 | 2009-01-30 | 379 |
| K022260 | Isolation Systems, Inc. | FAILSAFE - PORTABLE INFECTION CONTROL SYSTEMS | 2002-08-29 | 62 |
| K944133 | Mark Solutions, Inc. | MTB 1043 TREATMENT BOOTH | 1995-09-07 | 379 |
Recalls for LGM devices
1 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2014-06-27.
Frequently asked questions
What is FDA product code LGM?
LGM is the FDA product code for chamber, patient isolation. It is a Class II device, regulated under 21 CFR 880.5450 and reviewed by the General Hospital panel.
What device class is LGM?
Class II, regulation 21 CFR 880.5450. Typical premarket route: 510(k).
How long does a 510(k) take for product code LGM?
Across 12 cleared submissions the average was 170 days from receipt to decision (median 122).
Which companies have the most LGM clearances?
Carecubes, Inc. (1); Isovac Products, LLC (1); Gentex Corporation (1); Isolation Systems, Inc. (1); Mark Solutions, Inc. (1).
Have LGM devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2014-06-27.
Next steps
- Run an FDA pathway report with predicate devices for product code LGM
- Run a recall and safety report across every LGM manufacturer
- Watch product code LGM for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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