FDA product code DXG: Computer, Diagnostic, Pre-Programmed, Single-Function
DXG is the FDA product code for computer, diagnostic, pre-programmed, single-function. It is a Class II device, regulated under 21 CFR 870.1435 and reviewed by the Cardiovascular panel. FDA has cleared 177 510(k) submissions under DXG, 3 in the last five years, from 106 different applicants. The average 510(k) review took 130 days (median 96); 149 days on average over the last three years. FDA has posted 8 recalls for DXG devices.
Classification
| Field | Value |
|---|---|
| Device name | Computer, Diagnostic, Pre-Programmed, Single-Function |
| Device class | Class II |
| Regulation | 21 CFR 870.1435 |
| Review panel | CV — Cardiovascular |
| Medical specialty | Cardiovascular |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
510(k) clearances per year for DXG
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 1 | 189 |
| 2018 | 2 | 190 |
| 2019 | 2 | 130 |
| 2020 | 1 | 265 |
| 2021 | 1 | 104 |
| 2023 | 1 | 163 |
| 2025 | 1 | 155 |
| 2026 | 1 | 143 |
Compare with all 510(k) review times · Search every DXG clearance
Top DXG applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Edwards Lifesciences, LLC | 10 | 2019-12-17 |
| Lidco, Ltd. | 7 | 2017-06-05 |
| Hewlett-Packard Co. | 6 | 1985-04-09 |
| Transonic Systems, Inc. | 5 | 2015-01-29 |
| Abbott Laboratories | 4 | 2002-07-12 |
101 more applicants have DXG clearances. See the full list in Caduvo.
Most recent DXG clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K253092 | Retia Medical Systems, Inc. | Argos Infinity (Rev. 1.0) | 2026-02-13 | 143 |
| K251275 | Caretaker Medical | VitalStream ART Connect; VitalStream-Hemo | 2025-09-26 | 155 |
| K232048 | Icu Medical | Cogent Hemodynamic Monitoring System; Cogent HMS | 2023-12-20 | 163 |
| K212529 | Directed Systems, Ltd. | Hypotension Decision Assist Model HDA-OR2 | 2021-11-23 | 104 |
| K192169 | Pulsion Medical Systems SE | PulsioFlex Monitoring System with ProAQT Sensor | 2020-04-30 | 265 |
Recalls for DXG devices
8 product recalls in 8 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2020-11-19.
| Year | Recalls |
|---|---|
| 2019 | 1 |
| 2020 | 3 |
Frequently asked questions
What is FDA product code DXG?
DXG is the FDA product code for computer, diagnostic, pre-programmed, single-function. It is a Class II device, regulated under 21 CFR 870.1435 and reviewed by the Cardiovascular panel.
What device class is DXG?
Class II, regulation 21 CFR 870.1435. Typical premarket route: 510(k).
How long does a 510(k) take for product code DXG?
Across 177 cleared submissions the average was 130 days from receipt to decision (median 96).
Which companies have the most DXG clearances?
Edwards Lifesciences, LLC (10); Lidco, Ltd. (7); Hewlett-Packard Co. (6); Transonic Systems, Inc. (5); Abbott Laboratories (4).
Have DXG devices been recalled?
Yes: 8 product recalls across 8 recall events; the most recent began 2020-11-19.
Next steps
- Run an FDA pathway report with predicate devices for product code DXG
- Run a recall and safety report across every DXG manufacturer
- Watch product code DXG 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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