FDA product code KXO: Monitor, Pressure, Intrauterine
KXO is the FDA product code for monitor, pressure, intrauterine. It is a Class II device, regulated under 21 CFR 884.2700 and reviewed by the Obstetrics and Gynecology panel. FDA has cleared 26 510(k) submissions under KXO, from 14 different applicants. The average 510(k) review took 139 days (median 87).
Classification
| Field | Value |
|---|---|
| Device name | Monitor, Pressure, Intrauterine |
| Device class | Class II |
| Regulation | 21 CFR 884.2700 |
| 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 KXO clearance
Top KXO applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Graphic Controls Corp. | 5 | 1998-07-14 |
| Spectramed, Inc. | 4 | 1990-01-19 |
| Medex, Inc. | 3 | 1994-06-14 |
| Telos Medical Corp. | 2 | 1992-04-03 |
| Utah Medical Products, Inc. | 2 | 1991-06-19 |
9 more applicants have KXO clearances. See the full list in Caduvo.
Most recent KXO clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K991235 | Ludlow Technical Products | SOFTRANS TEMP INTRAUTERINE PRESSURE CATHETER SYSTEM (IUP 5000, SOFTRANS TEMP IUPC) | 1999-07-08 | 87 |
| K982565 | Carl Schuh | EASY TRANS TIP | 1998-09-22 | 61 |
| K974730 | Graphic Controls Corp. | SOFTRANS PLUS INTRAUTERINE PRESSURE CATHETER SYSTEM (IUP 5000, SOFTRANS PLUS IUPC) | 1998-07-14 | 208 |
| K964279 | Graphic Controls Corp. | SOFTRANS INTRAUTERINE PRESSURE CATHETER SYSTEM (IUP 4000 SOFTRANS IUPC) | 1997-01-22 | 86 |
| K961290 | Scientific Device Manufacturer, LLC | IUP - TIP TRANS, IUP - PROXI TRANS | 1996-10-15 | 194 |
Recalls for KXO devices
openFDA lists no recalls for product code KXO.
Frequently asked questions
What is FDA product code KXO?
KXO is the FDA product code for monitor, pressure, intrauterine. It is a Class II device, regulated under 21 CFR 884.2700 and reviewed by the Obstetrics and Gynecology panel.
What device class is KXO?
Class II, regulation 21 CFR 884.2700. Typical premarket route: 510(k).
How long does a 510(k) take for product code KXO?
Across 26 cleared submissions the average was 139 days from receipt to decision (median 87).
Which companies have the most KXO clearances?
Graphic Controls Corp. (5); Spectramed, Inc. (4); Medex, Inc. (3); Telos Medical Corp. (2); Utah Medical Products, Inc. (2).
Next steps
- Run an FDA pathway report with predicate devices for product code KXO
- Run a recall and safety report across every KXO manufacturer
- Watch product code KXO 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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