FDA product code MLO: Electrocardiograph, Ambulatory, With Analysis Algorithm
MLO is the FDA product code for electrocardiograph, ambulatory, with analysis algorithm. It is a Class II device, regulated under 21 CFR 870.2800 and reviewed by the Cardiovascular panel. FDA has cleared 33 510(k) submissions under MLO, 3 in the last five years, from 26 different applicants. The average 510(k) review took 192 days (median 183); 206 days on average over the last three years. FDA has posted 2 recalls for MLO devices, 2 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Electrocardiograph, Ambulatory, With Analysis Algorithm |
| Device class | Class II |
| Regulation | 21 CFR 870.2800 |
| Review panel | CV — Cardiovascular |
| Medical specialty | Cardiovascular |
| Premarket route | 510(k) |
510(k) clearances per year for MLO
| Year | Clearances | Avg. review days |
|---|---|---|
| 2018 | 1 | 101 |
| 2020 | 2 | 219 |
| 2024 | 1 | 231 |
| 2025 | 1 | 266 |
| 2026 | 1 | 121 |
Compare with all 510(k) review times · Search every MLO clearance
Top MLO applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Inovise Medical, Inc. | 3 | 2013-10-11 |
| Agilent Technologies | 3 | 2001-09-28 |
| Galix Biomedical Instrumentation, Inc. | 2 | 2010-07-09 |
| Novacor | 2 | 2005-01-19 |
| Zymed Medical Instrumentation | 2 | 1999-07-28 |
21 more applicants have MLO clearances. See the full list in Caduvo.
Most recent MLO clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K261580 | Zbeats, Inc. | ZBPro Diagnostic (Version 2.0) | 2026-09-11 | 121 |
| K241890 | Philips Medizin Systeme Böblingen GmbH | Philips Holter Analysis System | 2025-03-21 | 266 |
| K240794 | Fourth Frontier Technologies Pvt, Ltd. | Frontier X Plus | 2024-11-08 | 231 |
| K200833 | VivaQuant, Inc. | RX-1 Rhythm Express Remote Cardiac Monitoring System | 2020-09-02 | 156 |
| K193177 | Cardiocalm | CER-S | 2020-08-26 | 282 |
Recalls for MLO devices
2 product recalls in 1 recall events; 2 initiated in the last five years and 2 still open. Most recent: 2024-10-11.
| Year | Recalls |
|---|---|
| 2024 | 2 |
Frequently asked questions
What is FDA product code MLO?
MLO is the FDA product code for electrocardiograph, ambulatory, with analysis algorithm. It is a Class II device, regulated under 21 CFR 870.2800 and reviewed by the Cardiovascular panel.
What device class is MLO?
Class II, regulation 21 CFR 870.2800. Typical premarket route: 510(k).
How long does a 510(k) take for product code MLO?
Across 33 cleared submissions the average was 192 days from receipt to decision (median 183).
Which companies have the most MLO clearances?
Inovise Medical, Inc. (3); Agilent Technologies (3); Galix Biomedical Instrumentation, Inc. (2); Novacor (2); Zymed Medical Instrumentation (2).
Have MLO devices been recalled?
Yes: 2 product recalls across 1 recall events; the most recent began 2024-10-11.
Next steps
- Run an FDA pathway report with predicate devices for product code MLO
- Run a recall and safety report across every MLO manufacturer
- Watch product code MLO 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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