FDA product code KXN: Monitor, Cardiac, Fetal
KXN is the FDA product code for monitor, cardiac, fetal. It is a Class II device, regulated under 21 CFR 884.2600 and reviewed by the Obstetrics and Gynecology panel. FDA has cleared 2 510(k) submissions under KXN, from 2 different applicants. The average 510(k) review took 25 days (median 25). FDA has posted 1 recall for KXN devices.
Classification
| Field | Value |
|---|---|
| Device name | Monitor, Cardiac, Fetal |
| Device class | Class II |
| Regulation | 21 CFR 884.2600 |
| Review panel | OB — Obstetrics and Gynecology |
| Medical specialty | Obstetrics/Gynecology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
Compare with all 510(k) review times · Search every KXN clearance
Top KXN applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Mennen Greatbatch Electonics | 1 | 1977-02-14 |
| Hewlett-Packard Co. | 1 | 1976-12-17 |
Most recent KXN clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K770245 | Mennen Greatbatch Electonics | ABDOMINAL FETAL ECG MODULE | 1977-02-14 | 7 |
| K760968 | Hewlett-Packard Co. | CENTRAL STATION REPEATER (MODEL 8032A) | 1976-12-17 | 43 |
Recalls for KXN devices
1 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2004-09-17.
Frequently asked questions
What is FDA product code KXN?
KXN is the FDA product code for monitor, cardiac, fetal. It is a Class II device, regulated under 21 CFR 884.2600 and reviewed by the Obstetrics and Gynecology panel.
What device class is KXN?
Class II, regulation 21 CFR 884.2600. Typical premarket route: 510(k).
How long does a 510(k) take for product code KXN?
Across 2 cleared submissions the average was 25 days from receipt to decision (median 25).
Which companies have the most KXN clearances?
Mennen Greatbatch Electonics (1); Hewlett-Packard Co. (1).
Have KXN devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2004-09-17.
Next steps
- Run an FDA pathway report with predicate devices for product code KXN
- Run a recall and safety report across every KXN manufacturer
- Watch product code KXN 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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