FDA product code KXH: Cradle, Patient, Radiologic
KXH is the FDA product code for cradle, patient, radiologic. It is a Class I device, regulated under 21 CFR 892.1830 and reviewed by the Radiology panel. FDA has cleared 9 510(k) submissions under KXH, from 5 different applicants. The average 510(k) review took 121 days (median 101). FDA has posted 2 recalls for KXH devices.
Classification
| Field | Value |
|---|---|
| Device name | Cradle, Patient, Radiologic |
| Device class | Class I |
| Regulation | 21 CFR 892.1830 |
| Review panel | RA — Radiology |
| Medical specialty | Radiology |
| Premarket route | 510(k) exempt |
Top KXH applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Octostop, Inc. | 3 | 1995-09-29 |
| Spectrum X-Ray Corp. | 3 | 1993-10-07 |
| Ge Healthcare Coils (Usa Instruments, Inc.) | 1 | 2012-11-16 |
| Fischer Imaging Corp. | 1 | 1989-03-31 |
| Ar Custom Medical Products, Ltd. | 1 | 1986-10-14 |
Most recent KXH clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K122174 | Ge Healthcare Coils (Usa Instruments, Inc.) | PEDIATRIC POSITIONER PAD SET | 2012-11-16 | 116 |
| K953246 | Octostop, Inc. | OCTOROLL | 1995-09-29 | 80 |
| K930124 | Octostop, Inc. | VARIANT OF OCTOSTOP AND OCTOPAQUE | 1994-02-09 | 393 |
| K933134 | Spectrum X-Ray Corp. | SPECTRUM DG-P7000 PEDIATRIC CRADLE | 1993-10-07 | 101 |
| K930357 | Octostop, Inc. | ACCESSORY TO UNIVERSAL OCTOPAQUE | 1993-07-13 | 168 |
Recalls for KXH devices
2 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2017-08-10.
| Year | Recalls |
|---|---|
| 2017 | 2 |
Frequently asked questions
What is FDA product code KXH?
KXH is the FDA product code for cradle, patient, radiologic. It is a Class I device, regulated under 21 CFR 892.1830 and reviewed by the Radiology panel.
What device class is KXH?
Class I, regulation 21 CFR 892.1830. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code KXH?
Across 9 cleared submissions the average was 121 days from receipt to decision (median 101).
Which companies have the most KXH clearances?
Octostop, Inc. (3); Spectrum X-Ray Corp. (3); Ge Healthcare Coils (Usa Instruments, Inc.) (1); Fischer Imaging Corp. (1); Ar Custom Medical Products, Ltd. (1).
Have KXH devices been recalled?
Yes: 2 product recalls across 1 recall events; the most recent began 2017-08-10.
Next steps
- Run an FDA pathway report with predicate devices for product code KXH
- Run a recall and safety report across every KXH manufacturer
- Watch product code KXH 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.