FDA product code LYH: Arthrometer
LYH is the FDA product code for arthrometer. It is a Class I device, regulated under 21 CFR 890.1615 and reviewed by the Neurology panel. FDA has cleared 5 510(k) submissions under LYH, from 3 different applicants. The average 510(k) review took 134 days (median 144).
Classification
| Field | Value |
|---|---|
| Device name | Arthrometer |
| Device class | Class I |
| Regulation | 21 CFR 890.1615 |
| Review panel | NE — Neurology |
| Medical specialty | Physical Medicine |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every LYH clearance
Top LYH applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Medmetric Corp. | 3 | 1995-03-02 |
| Dyonics, Inc. | 1 | 1988-11-17 |
| Far Orthopedics, Inc. | 1 | 1984-02-09 |
Most recent LYH clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K943197 | Medmetric Corp. | KT1000/S KNEE LIGAMENT ARTHROMETER | 1995-03-02 | 240 |
| K942059 | Medmetric Corp. | KT2000 KNEE LIGAMENT ARTHROMETER | 1994-09-20 | 144 |
| K881876 | Dyonics, Inc. | DYNAMIC CRUCIATE TESTER | 1988-11-17 | 197 |
| K834462 | Far Orthopedics, Inc. | GENUCOM | 1984-02-09 | 52 |
| K812806 | Medmetric Corp. | KT-1000 DEVICE | 1981-11-10 | 35 |
Recalls for LYH devices
openFDA lists no recalls for product code LYH.
Frequently asked questions
What is FDA product code LYH?
LYH is the FDA product code for arthrometer. It is a Class I device, regulated under 21 CFR 890.1615 and reviewed by the Neurology panel.
What device class is LYH?
Class I, regulation 21 CFR 890.1615. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code LYH?
Across 5 cleared submissions the average was 134 days from receipt to decision (median 144).
Which companies have the most LYH clearances?
Medmetric Corp. (3); Dyonics, Inc. (1); Far Orthopedics, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code LYH
- Run a recall and safety report across every LYH manufacturer
- Watch product code LYH 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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