FDA product code MLD: Monitor, St Segment With Alarm
MLD is the FDA product code for monitor, st segment with alarm. It is a Class II device, regulated under 21 CFR 870.1025 and reviewed by the Cardiovascular panel. FDA has cleared 14 510(k) submissions under MLD, from 11 different applicants. The average 510(k) review took 207 days (median 129). FDA has posted 2 recalls for MLD devices.
Classification
| Field | Value |
|---|---|
| Device name | Monitor, St Segment With Alarm |
| Device class | Class II |
| Regulation | 21 CFR 870.1025 |
| Review panel | CV — Cardiovascular |
| Medical specialty | Cardiovascular |
| Premarket route | 510(k) |
Compare with all 510(k) review times · Search every MLD clearance
Top MLD applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Datex-Ohmeda | 2 | 2002-11-14 |
| Siemens Medical Solutions USA, Inc. | 2 | 2000-12-05 |
| Hewlett-Packard Co. | 2 | 1996-06-14 |
| Criticare Systems, Inc. | 1 | 2010-09-01 |
| Philips Medical Systems | 1 | 2008-03-13 |
6 more applicants have MLD clearances. See the full list in Caduvo.
Most recent MLD clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K101602 | Criticare Systems, Inc. | VITAL SIGNS MONITOR | 2010-09-01 | 85 |
| K080461 | Philips Medical Systems | STAR ST AND ARRHYTHMIA SOFTWARE, RELEASE J.0 | 2008-03-13 | 22 |
| K022740 | Datex-Ohmeda | DATEX-OHMEDA S/5 COMPACT CRITICAL CARE MONITOR WITH L-CICU02 & L-CICU02A SOFTWARE | 2002-11-14 | 87 |
| K012837 | Datex-Ohmeda | MODIFICATION TO: DATEX-OHMEDA CARDIOCAP 5 (REV B) AND ACCESSORIES | 2001-09-14 | 22 |
| K002105 | Siemens Medical Solutions USA, Inc. | SIEMENS INFINITY SC 6002XL ENHANCED WITH ST SEGMENT ANALYSIS | 2000-12-05 | 146 |
Recalls for MLD devices
2 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2006-02-06.
Frequently asked questions
What is FDA product code MLD?
MLD is the FDA product code for monitor, st segment with alarm. It is a Class II device, regulated under 21 CFR 870.1025 and reviewed by the Cardiovascular panel.
What device class is MLD?
Class II, regulation 21 CFR 870.1025. Typical premarket route: 510(k).
How long does a 510(k) take for product code MLD?
Across 14 cleared submissions the average was 207 days from receipt to decision (median 129).
Which companies have the most MLD clearances?
Datex-Ohmeda (2); Siemens Medical Solutions USA, Inc. (2); Hewlett-Packard Co. (2); Criticare Systems, Inc. (1); Philips Medical Systems (1).
Have MLD devices been recalled?
Yes: 2 product recalls across 1 recall events; the most recent began 2006-02-06.
Next steps
- Run an FDA pathway report with predicate devices for product code MLD
- Run a recall and safety report across every MLD manufacturer
- Watch product code MLD 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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