K1000 Ac-029
by AliveCor
K1000 Ac-029 is a Class II device made by AliveCor, cleared under FDA 510(k) K210753 on 30 Jun 2021 and listed in FDA GUDID since 18 Mar 2025 (UDI-DI B210AC0290), active as of 23 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | NumberB210AC0290 | Date18 Mar 2025 | StatusListed |
| United States | FDA 510(k)SESE | NumberK210753 | Date30 Jun 2021 | StatusActive |
Official records
- FDA 510(k) database K210753
Across registries
- FDA 510(k) K210753 decided 30 Jun 2021 Active
- FDA GUDID UDI-DI B210AC0290 listed 18 Mar 2025 Listed
Timeline
- Cleared FDA 510(k) K210753
- Listed FDA GUDID B210AC0290
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- K1000
- Generic name
- Electrocardiograph, professional, multichannel
- Model / reference
- AC-029
- Primary DI / UDI-DI
- B210AC0290
- FDA product code
- DPS, DXH
- GMDN term
- Electrocardiograph, professional, multichannel
- Device class
- Class II
- Regulation number
- 870.2340, 870.2920
- GUDID distribution status
- In Commercial Distribution
- MRI safety
- MR Unsafe
Similar devices
Other devices filed under FDA product code DPS (Electrocardiograph).
- Welch Allyn, Inc. 901129 ELI150C-BCB-AAGAX by Welch Allyn, Inc.
- Patient Monitor iM60 by Edan Instruments, Inc.
- Welch Allyn, Inc. 901132 ELI280-ADA-ABFBX by Welch Allyn, Inc.
- Electrocardiograph SE-3 by Edan Instruments, Inc.
- Cardiovit AT-102 G2 by Schiller AG
- PHILIPS 12-LEAD ALGORITHM by Philips Medical Systems
- PERSONAL C3 3-CHANNEL ELECTROCARDIOGRAPH by Parexel Intl. Corp.
- CARDIOFAX ECG-6353 by NIHON KOHDEN AMERICA, INC.
- ELECTROCARDIOGRAPH CM3000 by Philips Medical Systems (Cleveland), Inc.
- BMT ANSCORE HEALTH MANAGEMENT SYSTEM by Boston Medical Technologies, Inc.