Fever therometer MP-IRT350-US

by Better Basics, Inc.

Fever therometer MP-IRT350-US is a Class II device made by Better Basics, Inc., cleared under FDA 510(k) K131243 on 12 Nov 2013 and listed in FDA GUDID since 18 Nov 2016 (UDI-DI 00817746020274), 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

FDA submission, from GUDID

Trust

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

Region	Authorization	Number	Date	Status
United States	GUDID listing	Number00817746020274 UDI-DI	Date18 Nov 2016Listed	StatusListed GUDID: in commercial distribution
United States	FDA 510(k)SESE from GUDID Substantially Equivalent · Traditional	NumberK131243	Date12 Nov 2013Decided	StatusActive

Official records

AccessGUDID record UDI-DI 00817746020274
FDA 510(k) database 510(k) number K131243

Across registries

2 registries list this device

FDA 510(k) K131243 decided 12 Nov 2013 Active
FDA GUDID UDI-DI 00817746020274 listed 18 Nov 2016 Listed

Timeline

2 dated events

12 Nov 2013 Cleared FDA 510(k) K131243
18 Nov 2016 Listed FDA GUDID 00817746020274

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name: Fever therometer
Generic name: Infrared patient thermometer, skin
Model / reference: MP-IRT350-US

Primary DI / UDI-DI: 00817746020274
510(k) Number: K131243
FDA product code: FLL
GMDN term: Infrared patient thermometer, skin

Device class: Class II
Regulation number: 880.2910
GUDID distribution status: In Commercial Distribution

Similar devices in this category

Other devices filed under Infrared patient thermometer, skin.

Other devices from Better Basics, Inc.

See all devices from Better Basics, Inc. →

Properties

Serial number

Other properties (14, all answered No)