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Caring Mill UT-801-FSA

by Caring Mill

Caring Mill UT-801-FSA is a Class II device made by Caring Mill, cleared under FDA 510(k) K162083 on 9 Jan 2017 and listed in FDA GUDID since 26 Jul 2021 (UDI-DI 00810025921088), active as of 22 Oct 2026.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

510(k) K162083

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00810025921088 UDI-DI Date26 Jul 2021ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK162083 Date9 Jan 2017DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K162083 decided 9 Jan 2017 Active
  • FDA GUDID UDI-DI 00810025921088 listed 26 Jul 2021 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K162083
  2. Listed FDA GUDID 00810025921088

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Caring Mill
Generic name
Infrared patient thermometer, ear
Model / Ref / Catalog
UT-801-FSA
Primary DI / UDI-DI
00810025921088
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

Related devices

Category: Infrared patient thermometer, skinInfrared patient thermometer, ear

Similar devices

Other devices filed under FDA product code FLL (Thermometer, Electronic, Clinical).

Other devices from Caring Mill

See all devices from Caring Mill →

Properties

  • Over-the-counter
  • Serial number
Other properties (13, all answered No)