FDA product code LDE: Stethoscope, Manual
LDE is the FDA product code for stethoscope, manual. It is a Class I device, regulated under 21 CFR 870.1875 and reviewed by the Cardiovascular panel. FDA has cleared 28 510(k) submissions under LDE, from 25 different applicants. The average 510(k) review took 94 days (median 66).
Classification
| Field | Value |
|---|---|
| Device name | Stethoscope, Manual |
| Device class | Class I |
| Regulation | 21 CFR 870.1875 |
| Review panel | CV — Cardiovascular |
| Medical specialty | Cardiovascular |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every LDE clearance
Top LDE applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Conphar, Inc. | 3 | 1980-06-04 |
| Cher Mel Corp. | 2 | 1985-06-06 |
| Cypress Medical Products, Ltd. | 1 | 1994-12-08 |
| Rud Riester GmbH & CO KG | 1 | 1994-11-30 |
| Bhs Intl., Inc. | 1 | 1994-04-26 |
20 more applicants have LDE clearances. See the full list in Caduvo.
Most recent LDE clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K945082 | Cypress Medical Products, Ltd. | CYPRESS MEDICAL PRODUCTS STETHOSCOPE | 1994-12-08 | 52 |
| K944337 | Rud Riester GmbH & CO KG | VARIOUS STETHOSCOPES | 1994-11-30 | 85 |
| K940578 | Bhs Intl., Inc. | MANUAL STETOSCOPE | 1994-04-26 | 77 |
| K935944 | American Diagnostic Corp. | PROSCOPES AND ADSCOPES | 1994-03-03 | 80 |
| K923327 | Anup Chakraborty Co. | STETHOSCOPE COVER | 1992-11-03 | 119 |
Recalls for LDE devices
openFDA lists no recalls for product code LDE.
Frequently asked questions
What is FDA product code LDE?
LDE is the FDA product code for stethoscope, manual. It is a Class I device, regulated under 21 CFR 870.1875 and reviewed by the Cardiovascular panel.
What device class is LDE?
Class I, regulation 21 CFR 870.1875. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code LDE?
Across 28 cleared submissions the average was 94 days from receipt to decision (median 66).
Which companies have the most LDE clearances?
Conphar, Inc. (3); Cher Mel Corp. (2); Cypress Medical Products, Ltd. (1); Rud Riester GmbH & CO KG (1); Bhs Intl., Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code LDE
- Run a recall and safety report across every LDE manufacturer
- Watch product code LDE 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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