FDA product code LEL: Device, Sleep Assessment
LEL is the FDA product code for device, sleep assessment. It is a Class II device, regulated under 21 CFR 882.5050 and reviewed by the Neurology panel. FDA has cleared 19 510(k) submissions under LEL, 6 in the last five years, from 18 different applicants. The average 510(k) review took 141 days (median 96); 134 days on average over the last three years.
Classification
| Field | Value |
|---|---|
| Device name | Device, Sleep Assessment |
| Device class | Class II |
| Regulation | 21 CFR 882.5050 |
| Review panel | NE — Neurology |
| Medical specialty | Neurology |
| Premarket route | 510(k) |
510(k) clearances per year for LEL
| Year | Clearances | Avg. review days |
|---|---|---|
| 2018 | 1 | 30 |
| 2023 | 1 | 28 |
| 2024 | 2 | 162 |
| 2025 | 3 | 107 |
Compare with all 510(k) review times · Search every LEL clearance
Top LEL applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Cadwell Laboratories, Inc. | 2 | 2004-07-01 |
| Empatica S.r.l. | 1 | 2025-12-22 |
| Ambulatory Monitoring, Inc. | 1 | 2025-07-31 |
| Pneumowave, Ltd. | 1 | 2025-04-16 |
| Arbor Medical Innovations, LLC | 1 | 2024-06-17 |
13 more applicants have LEL clearances. See the full list in Caduvo.
Most recent LEL clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K252981 | Empatica S.r.l. | EmbraceMini | 2025-12-22 | 96 |
| K251574 | Ambulatory Monitoring, Inc. | Sleep Watch | 2025-07-31 | 70 |
| K243513 | Pneumowave, Ltd. | DCM (PW-DCM) | 2025-04-16 | 155 |
| K233987 | Arbor Medical Innovations, LLC | VERABAND | 2024-06-17 | 182 |
| K233618 | Oxehealth Limited | Oxevision Sleep Device | 2024-04-03 | 142 |
Recalls for LEL devices
openFDA lists no recalls for product code LEL.
Frequently asked questions
What is FDA product code LEL?
LEL is the FDA product code for device, sleep assessment. It is a Class II device, regulated under 21 CFR 882.5050 and reviewed by the Neurology panel.
What device class is LEL?
Class II, regulation 21 CFR 882.5050. Typical premarket route: 510(k).
How long does a 510(k) take for product code LEL?
Across 19 cleared submissions the average was 141 days from receipt to decision (median 96).
Which companies have the most LEL clearances?
Cadwell Laboratories, Inc. (2); Empatica S.r.l. (1); Ambulatory Monitoring, Inc. (1); Pneumowave, Ltd. (1); Arbor Medical Innovations, LLC (1).
Next steps
- Run an FDA pathway report with predicate devices for product code LEL
- Run a recall and safety report across every LEL manufacturer
- Watch product code LEL 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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