FDA product code OSP: Uterine Electromyographic Monitor
OSP is the FDA product code for uterine electromyographic monitor. It is a Class II device, regulated under 21 CFR 884.2720 and reviewed by the Obstetrics and Gynecology panel. FDA has cleared 10 510(k) submissions under OSP, from 6 different applicants. The average 510(k) review took 306 days (median 261). FDA has posted 3 recalls for OSP devices.
Definition
The uterine electromyographic monitor is intended to pick up uterine emg signals from surface electrodes placed on the maternal abdomen. It produces a uterine activity tracing and monitors women in labor at term gestation with a singleton pregnancy.
Classification
| Field | Value |
|---|---|
| Device name | Uterine Electromyographic Monitor |
| Device class | Class II |
| Regulation | 21 CFR 884.2720 |
| Review panel | OB — Obstetrics and Gynecology |
| Medical specialty | Obstetrics/Gynecology |
| Premarket route | 510(k) |
510(k) clearances per year for OSP
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 1 | 455 |
| 2020 | 1 | 540 |
Compare with all 510(k) review times · Search every OSP clearance
Top OSP applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Obmedical Company | 2 | 2020-09-18 |
| Monica Healthcare, Ltd. | 2 | 2014-08-27 |
| Reproductive Research Technologies, LP | 2 | 2013-06-28 |
| Monica Healthcare | 2 | 2011-08-30 |
| Nemo Healthcare BV | 1 | 2017-02-07 |
1 more applicants have OSP clearances. See the full list in Caduvo.
Most recent OSP clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K190798 | Obmedical Company | LaborView LV1000 Wireless Electrode System | 2020-09-18 | 540 |
| K153262 | Nemo Healthcare BV | PUREtrace | 2017-02-07 | 455 |
| K142583 | Obmedical Company | LaborView LV1000 | 2015-01-16 | 123 |
| K140862 | Monica Healthcare, Ltd. | MONICA NOVII WIRELESS PATCH SYSTEM | 2014-08-27 | 146 |
| K131889 | Promedic, Inc. | EUM 100PRO | 2014-04-23 | 302 |
Recalls for OSP devices
3 product recalls in 2 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2017-12-15.
| Year | Recalls |
|---|---|
| 2017 | 3 |
Frequently asked questions
What is FDA product code OSP?
OSP is the FDA product code for uterine electromyographic monitor. It is a Class II device, regulated under 21 CFR 884.2720 and reviewed by the Obstetrics and Gynecology panel.
What device class is OSP?
Class II, regulation 21 CFR 884.2720. Typical premarket route: 510(k).
How long does a 510(k) take for product code OSP?
Across 10 cleared submissions the average was 306 days from receipt to decision (median 261).
Which companies have the most OSP clearances?
Obmedical Company (2); Monica Healthcare, Ltd. (2); Reproductive Research Technologies, LP (2); Monica Healthcare (2); Nemo Healthcare BV (1).
Have OSP devices been recalled?
Yes: 3 product recalls across 2 recall events; the most recent began 2017-12-15.
Next steps
- Run an FDA pathway report with predicate devices for product code OSP
- Run a recall and safety report across every OSP manufacturer
- Watch product code OSP 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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