WorkMate Claris System— 510(k) K210392
Substantially EquivalentAbbott
FDA 510(k) clearance K210392 for WorkMate Claris System, Substantially Equivalent on 2021-03-11. Applicant: Abbott. Device class: 2.
Clearance details
- Applicant
- Abbott
- Product code
- Code DQK
- Device class
- Class 2
- Regulation
- 21 CFR 870.1425
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- St. Paul, MN, US
Recent devices under product code DQK
view allMore clearances from Abbott
view allAdverse events under product code DQK
product code DQK- Death
- 10
- Injury
- 225
- Malfunction
- 2,123
- Other
- 2
- Total
- 2,360
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recalls naming K210392
K-number listed on FDA's recall record- Z-1853-2021 — v.1.2 Upgrade Kit or v.1.2 upgrade installed on WorkMate Claris System, Model H700123. The WorkMate Claris" System is a computer-based electrocardiographic recording and monitoring system designed for efficient capture, display, and retrieval of surface and intracardiac signals during cardiac EP studies.
- Z-1854-2021 — v.1.2 Upgrade Kit or v.1.2 upgrade installed on WorkMate Claris" System Display, Model H700124, The WorkMate Claris" System is a computer-based electrocardiographic recording and monitoring system designed for efficient capture, display, and retrieval of surface and intracardiac signals during cardiac EP studies.
- Z-1855-2021 — WorkMate Claris v.1.2 Upgrade Kits, Model Numbers H800007 and H800012
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K210392.
Data sourced from openFDA. This site is unofficial and independent of the FDA.