Elate AL1

Elate AL1 is a Class II device made by Amplim, LLC, cleared under FDA 510(k) K210565 on 5 May 2022 and listed in FDA GUDID since 28 Jul 2022 (UDI-DI 00810477028052), 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	Number00810477028052 UDI-DI	Date28 Jul 2022Listed	StatusListed GUDID: in commercial distribution
United States	FDA 510(k)SESE from GUDID Substantially Equivalent · Traditional	NumberK210565	Date5 May 2022Decided	StatusActive

Official records

AccessGUDID record UDI-DI 00810477028052
FDA 510(k) database 510(k) number K210565

Across registries

2 registries list this device

FDA 510(k) K210565 decided 5 May 2022 Active
FDA GUDID UDI-DI 00810477028052 listed 28 Jul 2022 Listed

Timeline

2 dated events

5 May 2022 Cleared FDA 510(k) K210565
28 Jul 2022 Listed FDA GUDID 00810477028052

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name: Elate
Generic name: Infrared patient thermometer, skin
Model / reference: AL1

Primary DI / UDI-DI: 00810477028052
510(k) Number: K210565
FDA product code: FLL
GMDN term: Infrared patient thermometer, skin

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

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Other devices from Amplim, LLC

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Properties

Lot / batch number

Other properties (14, all answered No)