Pulse 1801814
Pulse 1801814 is a Class II device made by NuVasive, LLC, cleared under FDA 510(k) K210574 on 29 Jul 2021 and listed in FDA GUDID since 6 May 2022 (UDI-DI 00195377057020), active as of 23 Oct 2026. One FDA recall is linked to it.
Active
510(k)
Valid until
No expiry
FDA recalls
1 ongoingDocuments
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number00195377057020 | Date6 May 2022 | StatusListed |
| United States | FDA 510(k)SESE | NumberK210574 | Date29 Jul 2021 | StatusActive |
Official records
- AccessGUDID record 00195377057020
- FDA 510(k) database K210574
Across registries
- FDA 510(k) K210574 decided 29 Jul 2021 Active
- FDA GUDID UDI-DI 00195377057020 listed 6 May 2022 Listed
Recalls
-
- Ongoing Z-1052-2023
Due to an incorrect security key, customers were unable to connect to remote monitoring during spinal surgery, neck dissections, thoracic surgeries, and upper and lower extremity procedures.
Timeline
- Cleared FDA 510(k) K210574
- Listed FDA GUDID 00195377057020
- Recall initiated FDA recalls Z-1052-2023
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Pulse
- Generic name
- Diagnostic x-ray digital imaging system workstation
- Model / reference
- 1801814
- Primary DI / UDI-DI
- 00195377057020
- 510(k) Number
- FDA product code
- JAA, OLO, OWB, ETN, PDQ, IKN, LLZ, HAW, GWF
- GMDN term
- Diagnostic x-ray digital imaging system workstation
- Device class
- Class II
- Regulation number
- 892.1650, 882.4560, 874.1820, 890.1375, 892.2050, 882.1870
- GUDID distribution status
- In Commercial Distribution