FDA product code LGX: Table, Examination, Medical, Powered
LGX is the FDA product code for table, examination, medical, powered. It is a Class I device, regulated under 21 CFR 878.4960 and reviewed by the General Hospital panel. FDA has cleared 14 510(k) submissions under LGX, from 11 different applicants. The average 510(k) review took 63 days (median 34). FDA has posted 15 recalls for LGX devices, 4 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Table, Examination, Medical, Powered |
| Device class | Class I |
| Regulation | 21 CFR 878.4960 |
| Review panel | HO — General Hospital |
| Medical specialty | General, Plastic Surgery |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every LGX clearance
Top LGX applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Midmark Corp. | 4 | 1989-08-28 |
| Tri W-G, Inc. | 1 | 1995-02-17 |
| Hamilton Industries, Inc. | 1 | 1988-10-04 |
| Enochs Mfg., Inc. | 1 | 1988-07-13 |
| Cherne Industries, Inc. | 1 | 1986-11-07 |
6 more applicants have LGX clearances. See the full list in Caduvo.
Most recent LGX clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K945163 | Tri W-G, Inc. | ECHOCARDIOGRAPHY | 1995-02-17 | 119 |
| K894144 | Midmark Corp. | POWER EXAMINATION TABLE MODEL # 405 | 1989-08-28 | 76 |
| K894134 | Midmark Corp. | POWER EXAMINATION TABLE MODEL # 411 | 1989-08-28 | 76 |
| K883680 | Hamilton Industries, Inc. | MEDALIST EXAMINATION TABLE | 1988-10-04 | 36 |
| K882010 | Enochs Mfg., Inc. | POWER EXAMINATION TABLE | 1988-07-13 | 61 |
Recalls for LGX devices
15 product recalls in 8 recall events; 4 initiated in the last five years and 4 still open. Most recent: 2023-12-05.
| Year | Recalls |
|---|---|
| 2018 | 1 |
| 2019 | 1 |
| 2021 | 1 |
| 2023 | 4 |
Frequently asked questions
What is FDA product code LGX?
LGX is the FDA product code for table, examination, medical, powered. It is a Class I device, regulated under 21 CFR 878.4960 and reviewed by the General Hospital panel.
What device class is LGX?
Class I, regulation 21 CFR 878.4960. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code LGX?
Across 14 cleared submissions the average was 63 days from receipt to decision (median 34).
Which companies have the most LGX clearances?
Midmark Corp. (4); Tri W-G, Inc. (1); Hamilton Industries, Inc. (1); Enochs Mfg., Inc. (1); Cherne Industries, Inc. (1).
Have LGX devices been recalled?
Yes: 15 product recalls across 8 recall events; the most recent began 2023-12-05.
Next steps
- Run an FDA pathway report with predicate devices for product code LGX
- Run a recall and safety report across every LGX manufacturer
- Watch product code LGX 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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