FDA product code DXS: Gauge, Pressure, Coronary, Cardiopulmonary Bypass
DXS is the FDA product code for gauge, pressure, coronary, cardiopulmonary bypass. It is a Class II device, regulated under 21 CFR 870.4310 and reviewed by the Cardiovascular panel. FDA has cleared 13 510(k) submissions under DXS, from 10 different applicants. The average 510(k) review took 62 days (median 49). FDA has posted 5 recalls for DXS devices, 1 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Gauge, Pressure, Coronary, Cardiopulmonary Bypass |
| Device class | Class II |
| Regulation | 21 CFR 870.4310 |
| Review panel | CV — Cardiovascular |
| Medical specialty | Cardiovascular |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
Compare with all 510(k) review times · Search every DXS clearance
Top DXS applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Delta Medical Industries | 3 | 1983-07-26 |
| Shiley, Inc. | 2 | 1990-05-10 |
| Medtronic, Inc. | 1 | 2011-12-02 |
| Vascular Technology Incorporated | 1 | 1994-12-27 |
| Lifestream Int'L, Inc. | 1 | 1991-10-31 |
5 more applicants have DXS clearances. See the full list in Caduvo.
Most recent DXS clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K113235 | Medtronic, Inc. | PRESSURE DISPLAY BOX,DLP DISPOSABLE PRESSURE DISPLAY SETS-NON STERILE VERSIONS | 2011-12-02 | 30 |
| K944764 | Vascular Technology Incorporated | VTI DISPOSABLE PRESSURE DISPLAY SET | 1994-12-27 | 91 |
| K912045 | Lifestream Int'L, Inc. | TMP PRESSURE ISOLATORR, TMP PRESSURE MONITOR SYST | 1991-10-31 | 176 |
| K900797 | Shiley, Inc. | STOCKERT SHILEY DUAL PRESSURE CONTROL MODULE XR | 1990-05-10 | 79 |
| K873802 | American Omni Medical, Inc. | PRESSURE BARRIER KIT CAT. NO. PBK-3 | 1987-11-06 | 49 |
Recalls for DXS devices
5 product recalls in 3 recall events; 1 initiated in the last five years and 1 still open. Most recent: 2024-03-19.
| Year | Recalls |
|---|---|
| 2017 | 1 |
| 2024 | 1 |
Frequently asked questions
What is FDA product code DXS?
DXS is the FDA product code for gauge, pressure, coronary, cardiopulmonary bypass. It is a Class II device, regulated under 21 CFR 870.4310 and reviewed by the Cardiovascular panel.
What device class is DXS?
Class II, regulation 21 CFR 870.4310. Typical premarket route: 510(k).
How long does a 510(k) take for product code DXS?
Across 13 cleared submissions the average was 62 days from receipt to decision (median 49).
Which companies have the most DXS clearances?
Delta Medical Industries (3); Shiley, Inc. (2); Medtronic, Inc. (1); Vascular Technology Incorporated (1); Lifestream Int'L, Inc. (1).
Have DXS devices been recalled?
Yes: 5 product recalls across 3 recall events; the most recent began 2024-03-19.
Next steps
- Run an FDA pathway report with predicate devices for product code DXS
- Run a recall and safety report across every DXS manufacturer
- Watch product code DXS 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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