FDA product code LGN: Chamber, Patient Transport Isolation
LGN is the FDA product code for chamber, patient transport isolation. It is a Class II device, regulated under 21 CFR 880.5450 and reviewed by the General Hospital panel. FDA has cleared 2 510(k) submissions under LGN, from 2 different applicants. The average 510(k) review took 168 days (median 168).
Classification
| Field | Value |
|---|---|
| Device name | Chamber, Patient Transport 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 |
Compare with all 510(k) review times · Search every LGN clearance
Top LGN applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Isovac Products, LLC | 1 | 2006-06-06 |
| Vickers America Medical Corp. | 1 | 1979-07-03 |
Most recent LGN clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K052798 | Isovac Products, LLC | CAPSULS, MODELS 2003-PUR8C, 2004-PVC8C | 2006-06-06 | 246 |
| K790658 | Vickers America Medical Corp. | AIRCRAFT TRANSIT ISOLATOR MODEL 121 | 1979-07-03 | 89 |
Recalls for LGN devices
openFDA lists no recalls for product code LGN.
Frequently asked questions
What is FDA product code LGN?
LGN is the FDA product code for chamber, patient transport isolation. It is a Class II device, regulated under 21 CFR 880.5450 and reviewed by the General Hospital panel.
What device class is LGN?
Class II, regulation 21 CFR 880.5450. Typical premarket route: 510(k).
How long does a 510(k) take for product code LGN?
Across 2 cleared submissions the average was 168 days from receipt to decision (median 168).
Which companies have the most LGN clearances?
Isovac Products, LLC (1); Vickers America Medical Corp. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code LGN
- Run a recall and safety report across every LGN manufacturer
- Watch product code LGN 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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