FDA product code LXG: Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use
LXG is the FDA product code for equipment, laboratory, general purpose, labeled or promoted for a specific medical use. It is a Class I device, regulated under 21 CFR 862.2050 and reviewed by the Clinical Chemistry panel. FDA has cleared 3 510(k) submissions under LXG, from 3 different applicants. The average 510(k) review took 133 days (median 30). FDA has posted 28 recalls for LXG devices, 3 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use |
| Device class | Class I |
| Regulation | 21 CFR 862.2050 |
| Review panel | CH — Clinical Chemistry |
| Medical specialty | Clinical Chemistry |
| Premarket route | 510(k) exempt |
| GMP exempt | Yes |
Compare with all 510(k) review times · Search every LXG clearance
Top LXG applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Biomet, Inc. | 1 | 2002-07-12 |
| Cambridge Diagnostic Products, Inc. | 1 | 1995-05-24 |
| Westmark, Sterile Packing Systems, Inc. (Sps) | 1 | 1989-12-27 |
Most recent LXG clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K021927 | Biomet, Inc. | PLATELET CONCENTRATE SEPARATION KIT FOR CELSEP CENTRIFUGE SYSTEM | 2002-07-12 | 30 |
| K943466 | Cambridge Diagnostic Products, Inc. | MINI S.F.T. (URINE PRESERVATIVE) | 1995-05-24 | 343 |
| K896802 | Westmark, Sterile Packing Systems, Inc. (Sps) | MAGNET PAD | 1989-12-27 | 26 |
Recalls for LXG devices
28 product recalls in 18 recall events; 3 initiated in the last five years and 4 still open. Most recent: 2025-12-15.
| Year | Recalls |
|---|---|
| 2018 | 9 |
| 2019 | 2 |
| 2020 | 2 |
| 2023 | 1 |
| 2025 | 2 |
Frequently asked questions
What is FDA product code LXG?
LXG is the FDA product code for equipment, laboratory, general purpose, labeled or promoted for a specific medical use. It is a Class I device, regulated under 21 CFR 862.2050 and reviewed by the Clinical Chemistry panel.
What device class is LXG?
Class I, regulation 21 CFR 862.2050. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code LXG?
Across 3 cleared submissions the average was 133 days from receipt to decision (median 30).
Which companies have the most LXG clearances?
Biomet, Inc. (1); Cambridge Diagnostic Products, Inc. (1); Westmark, Sterile Packing Systems, Inc. (Sps) (1).
Have LXG devices been recalled?
Yes: 28 product recalls across 18 recall events; the most recent began 2025-12-15.
Next steps
- Run an FDA pathway report with predicate devices for product code LXG
- Run a recall and safety report across every LXG manufacturer
- Watch product code LXG 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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