OctiveTech FDIR-V1
OctiveTech FDIR-V1 is a Class II device made by Clinical Guard, cleared under FDA 510(k) K052849 on 26 Oct 2005 and listed in FDA GUDID since 4 Oct 2016 (UDI-DI 00897429002056), active as of 22 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 | Number00897429002056 | Date4 Oct 2016 | StatusListed |
| United States | FDA 510(k) | NumberK052849 | Date26 Oct 2005 | StatusActive |
Official records
- AccessGUDID record 00897429002056
- FDA 510(k) database K052849
Across registries
- FDA 510(k) K052849 decided 26 Oct 2005 Active
- FDA GUDID UDI-DI 00897429002056 listed 4 Oct 2016 Listed
Timeline
- Cleared FDA 510(k) K052849
- Listed FDA GUDID 00897429002056
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- OctiveTech
- Generic name
- Infrared patient thermometer, ear
- Model / reference
- FDIR-V1
- Primary DI / UDI-DI
- 00897429002056
- 510(k) Number
- FDA product code
- FLL
- GMDN term
- Infrared patient thermometer, ear
- Device class
- Class II
- Regulation number
- 880.2910
- GUDID distribution status
- In Commercial Distribution
Similar devices
Other devices filed under FDA product code FLL (Thermometer, Electronic, Clinical).
- R&D Batteries Part Nos. 5041 & 5655 by R & D BATTERIES, INC.
- E-Z Therm 3 Second Thermometer by North American Technical Services Corp.
- Disposable Temperature Probe by Shenzhen Caremed Medical Technology Co., Ltd.
- Thermoclick by T&R BIOFAB CO., LTD
- Unimed THP-PG by Unimed Medical Supplies, Inc.
- Radius T Wearable Thermometer by MASIMO CORPORATION
- Electronic Digital Fever Thermometer by North American Philips Corp.
- Electronic Clinical Thermometer (K780861) by TREND MEDICAL, LLC
- Thermometer, Survalent-Electronic by Arbrook Mfg. Corp.
- GT990402 Digital Thermometer by Global Treasure, Ltd.