FDA product code DXJ: Display, Cathode-Ray Tube, Medical
DXJ is the FDA product code for display, cathode-ray tube, medical. It is a Class II device, regulated under 21 CFR 870.2450 and reviewed by the Cardiovascular panel. FDA has cleared 78 510(k) submissions under DXJ, from 42 different applicants. The average 510(k) review took 132 days (median 92). FDA has posted 21 recalls for DXJ devices, 7 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Display, Cathode-Ray Tube, Medical |
| Device class | Class II |
| Regulation | 21 CFR 870.2450 |
| Review panel | CV — Cardiovascular |
| Medical specialty | Cardiovascular |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
510(k) clearances per year for DXJ
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 4 | 158 |
| 2018 | 4 | 169 |
| 2020 | 1 | 119 |
| 2021 | 2 | 106 |
Top DXJ applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Hewlett-Packard Co. | 7 | 1999-08-31 |
| Barco N.V. | 5 | 2018-02-22 |
| Vidco, Inc. | 5 | 1994-08-18 |
| Litton Medical Electronics | 5 | 1984-09-20 |
| Honeywell, Inc. | 4 | 1985-07-24 |
37 more applicants have DXJ clearances. See the full list in Caduvo.
Most recent DXJ clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K212003 | Livanova Deutschland, GmbH | ESSENZ Patient Monitor | 2021-11-10 | 135 |
| K212208 | Philips Medizin Systeme Boeblingen GmbH | Philips IntelliVue GuardianSoftware (Rev. E.0X) | 2021-09-30 | 77 |
| K201162 | Shenyang Torch-Bigtide Digital Technology Co., Ltd. | Essence 55SP Large Monitor System | 2020-08-27 | 119 |
| K173107 | Vios Medical, Inc. | Vios Central Station Monitor Software, Vios Central Server Software | 2018-07-26 | 300 |
| K180534 | Philips Medizin Systeme Boeblingen GmbH | Philips IntelliVue GuardianSoftware | 2018-07-16 | 138 |
Recalls for DXJ devices
21 product recalls in 17 recall events; 7 initiated in the last five years and 6 still open. Most recent: 2025-09-05.
| Year | Recalls |
|---|---|
| 2022 | 3 |
| 2024 | 1 |
| 2025 | 3 |
Frequently asked questions
What is FDA product code DXJ?
DXJ is the FDA product code for display, cathode-ray tube, medical. It is a Class II device, regulated under 21 CFR 870.2450 and reviewed by the Cardiovascular panel.
What device class is DXJ?
Class II, regulation 21 CFR 870.2450. Typical premarket route: 510(k).
How long does a 510(k) take for product code DXJ?
Across 78 cleared submissions the average was 132 days from receipt to decision (median 92).
Which companies have the most DXJ clearances?
Hewlett-Packard Co. (7); Barco N.V. (5); Vidco, Inc. (5); Litton Medical Electronics (5); Honeywell, Inc. (4).
Have DXJ devices been recalled?
Yes: 21 product recalls across 17 recall events; the most recent began 2025-09-05.
Next steps
- Run an FDA pathway report with predicate devices for product code DXJ
- Run a recall and safety report across every DXJ manufacturer
- Watch product code DXJ 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.