FDA product code LDK: Device, Sensing, Optical Contour
LDK is the FDA product code for device, sensing, optical contour. It is a Unclassified device, reviewed by the Physical Medicine panel. FDA has cleared 8 510(k) submissions under LDK, 2 in the last five years, from 8 different applicants. The average 510(k) review took 184 days (median 98).
Classification
| Field | Value |
|---|---|
| Device name | Device, Sensing, Optical Contour |
| Device class | Unclassified |
| Review panel | PM — Physical Medicine |
| Medical specialty | Unknown |
| Premarket route | 510(k) exempt |
510(k) clearances per year for LDK
| Year | Clearances | Avg. review days |
|---|---|---|
| 2019 | 1 | 254 |
| 2023 | 2 | 178 |
Compare with all 510(k) review times · Search every LDK clearance
Top LDK applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Nsite, Inc. | 1 | 2023-11-15 |
| Momentum Health, Inc. | 1 | 2023-10-04 |
| Cryos Technologies, Inc. | 1 | 2019-08-28 |
| Quantec Image Processing , Ltd. | 1 | 1994-04-20 |
| Far Orthopedics, Inc. | 1 | 1986-02-11 |
3 more applicants have LDK clearances. See the full list in Caduvo.
Most recent LDK clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K230463 | Nsite, Inc. | NSite Scoliosis Assessment App | 2023-11-15 | 267 |
| K232023 | Momentum Health, Inc. | Momentum Spine | 2023-10-04 | 89 |
| K183485 | Cryos Technologies, Inc. | CryoVizion System | 2019-08-28 | 254 |
| K923792 | Quantec Image Processing , Ltd. | QUANTEC SPINAL MEASUEMENT SYSTEM | 1994-04-20 | 631 |
| K860225 | Far Orthopedics, Inc. | METRICOM | 1986-02-11 | 20 |
Recalls for LDK devices
openFDA lists no recalls for product code LDK.
Frequently asked questions
What is FDA product code LDK?
LDK is the FDA product code for device, sensing, optical contour. It is a Unclassified device, reviewed by the Physical Medicine panel.
What device class is LDK?
Unclassified. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code LDK?
Across 8 cleared submissions the average was 184 days from receipt to decision (median 98).
Which companies have the most LDK clearances?
Nsite, Inc. (1); Momentum Health, Inc. (1); Cryos Technologies, Inc. (1); Quantec Image Processing , Ltd. (1); Far Orthopedics, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code LDK
- Run a recall and safety report across every LDK manufacturer
- Watch product code LDK 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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