Skip to content

Fever Garde HMT-100

by HuBDIC Co., Ltd.

Fever Garde HMT-100 is a Class II device made by HuBDIC Co., Ltd., cleared under FDA 510(k) K191978 on 18 Dec 2020 and listed in FDA GUDID since 13 Apr 2022 (UDI-DI 08800132200413), active as of 23 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 23 Oct 2026

Documents

510(k) K191978

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number08800132200413 UDI-DI Date13 Apr 2022ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK191978 Date18 Dec 2020DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K191978 decided 18 Dec 2020 Active
  • FDA GUDID UDI-DI 08800132200413 listed 13 Apr 2022 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K191978
  2. Listed FDA GUDID 08800132200413

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Fever Garde
Generic name
Wireless patient thermometer, reusable
Model / reference
HMT-100
Primary DI / UDI-DI
08800132200413
510(k) Number
FDA product code
FLL
GMDN term
Wireless patient thermometer, reusable
Device class
Class II
Regulation number
880.2910
GUDID distribution status
In Commercial Distribution

Related devices

Category: Wireless patient thermometer, reusable

Similar devices

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

Other devices from HuBDIC Co., Ltd.

See all devices from HuBDIC Co., Ltd. →

Properties

  • Over-the-counter
  • Lot / batch number
  • Serial number
  • Manufacturing date
Other properties (11, all answered No)