FDA product code LDG: Kit, Earmold, Impression
LDG is the FDA product code for kit, earmold, impression. It is a Class I device, regulated under 21 CFR 874.3300 and reviewed by the Ear, Nose and Throat panel. FDA has cleared 2 510(k) submissions under LDG, from 2 different applicants. The average 510(k) review took 74 days (median 74).
Classification
| Field | Value |
|---|---|
| Device name | Kit, Earmold, Impression |
| Device class | Class I |
| Regulation | 21 CFR 874.3300 |
| Review panel | EN — Ear, Nose and Throat |
| Medical specialty | Ear, Nose, Throat |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every LDG clearance
Top LDG applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Santa Barbara Medco, Inc. | 1 | 1983-03-28 |
| Coe Laboratories, Inc. | 1 | 1980-01-23 |
Most recent LDG clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K823921 | Santa Barbara Medco, Inc. | PHYSICIANS CHOICE SILICONE EAR PUTTY | 1983-03-28 | 90 |
| K792428 | Coe Laboratories, Inc. | COE-SIL | 1980-01-23 | 57 |
Recalls for LDG devices
openFDA lists no recalls for product code LDG.
Frequently asked questions
What is FDA product code LDG?
LDG is the FDA product code for kit, earmold, impression. It is a Class I device, regulated under 21 CFR 874.3300 and reviewed by the Ear, Nose and Throat panel.
What device class is LDG?
Class I, regulation 21 CFR 874.3300. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code LDG?
Across 2 cleared submissions the average was 74 days from receipt to decision (median 74).
Which companies have the most LDG clearances?
Santa Barbara Medco, Inc. (1); Coe Laboratories, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code LDG
- Run a recall and safety report across every LDG manufacturer
- Watch product code LDG 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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