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Clever Choice CLETEF-786

by Simple Diagnostics 2 variants

Clever Choice CLETEF-786 is a Class II device made by Simple Diagnostics, cleared under FDA 510(k) K181215 on 2 Jan 2019 and listed in FDA GUDID since 31 Aug 2020 (UDI-DI 00898302141886), 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) K181215

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 Number00898302141886 UDI-DI Date31 Aug 2020ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k) from GUDID NumberK181215 Date2 Jan 2019IssuedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K181215 decided 2 Jan 2019 Active
  • FDA GUDID UDI-DI 00898302141886 listed 31 Aug 2020 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K181215
  2. Listed FDA GUDID 00898302141886

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Clever Choice
Generic name
Infrared patient thermometer, skin
Model / Ref / Catalog
CLETEF-786
Primary DI / UDI-DI
00898302141886
510(k) Number
FDA product code
FLL
GMDN term
Infrared patient thermometer, skin
Device class
Class II
Regulation number
880.2910
GUDID distribution status
In Commercial Distribution

Related devices

Category: Infrared patient thermometer, skinInfrared patient thermometer, ear

Cleared under the same submission (K181215)

and 8 more cleared under K181215

Similar devices

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

Other devices from Simple Diagnostics

See all devices from Simple Diagnostics →

Properties

  • Over-the-counter
  • Lot / batch number
Other properties (13, all answered No)