Cardioserver
by Datrix
510(k) K052883
Cardioserver is a Class II device made by Datrix, cleared under FDA 510(k) K052883 on 1 Nov 2005, active as of 22 Oct 2026. One FDA recall is linked to it.
Active
Valid until
No expiry
FDA recalls
1 ongoingDocuments
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK052883 | Date1 Nov 2005 | StatusActive |
Official records
- FDA 510(k) database K052883
Recalls
-
- Ongoing Z-2647-2023
Epiphany, now a Baxter Healthcare company, is issuing an Urgent Medical Device Correction for the Cardio Server E3 ECG Management System software listed below due to a report of the caliper tool becoming non-responsive, preventing the caliper function from being used temporarily on software versions v6.1.x, v6.2.x, and v7.0.x of the E3 user interface.
Timeline
- Cleared FDA 510(k) K052883
- Recall initiated FDA recalls Z-2647-2023
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- DQK
- Device class
- Class II
- Regulation
- 21 CFR Part 870.1425
- Advisory committee
- Cardiovascular
- FDA decision
- SESE Substantially Equivalent
Devices cleared under K052883
Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.
| UDI-DI | Size and differences | |||
|---|---|---|---|---|
| Cardio Server 6.1 | 6.1 | 00860991000355 | On the market | |
| Cardio Server 6.2 | 6.2 | 00860991000362 | On the market | |
| Cardio Server 7.0 | 7.0 | 00860991000379 | On the market | |
| Cardio Server 7.1 | 7.1 | 00860991000386 | On the market | |
| Cardio Server 7.4.0 | 7.4.0 | 00860991000393 | On the market | |
| Cardio Server 901204 | 901204 | 00732094360295 | On the market | |
| Epiphany Cardio Server 5.1.0 | 5.1.0 | 00860991000300 | On the market | |
| Epiphany Cardio Server 5.2.0 | 5.2.0 | 00860991000317 | On the market | |
| Epiphany Cardio Server 5.3 | 5.3 | 00860991000324 | On the market | |
| Epiphany Cardio Server 5.4 | 5.4 | 00860991000331 | On the market | |
| Epiphany Cardio Server 6.0 | 6.0 | 00860991000348 | On the market |
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