Adtemp™ 416-5000

by American Diagnostic Corporation

Adtemp™ 416-5000 is a Class II device made by American Diagnostic Corporation, cleared under FDA 510(k) K202009 on 22 Mar 2021 (1 earlier submission) and listed in FDA GUDID since 27 Apr 2018 (UDI-DI 00634782548292), 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

+1 more

Trust

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

Region	Authorization	Number	Date	Status
United States	FDA 510(k)SESE from GUDID Substantially Equivalent · Traditional	NumberK202009	Date22 Mar 2021Decided	StatusActive
United States	GUDID listing	Number00634782548292 UDI-DI	Date27 Apr 2018Listed	StatusListed GUDID: in commercial distribution
United States	FDA 510(k)SESE from GUDID Substantially Equivalent · Traditional	NumberK940686	Date8 Jul 1994Decided	StatusActive

Official records

AccessGUDID record UDI-DI 00634782548292
FDA 510(k) database 510(k) number K202009
FDA 510(k) database 510(k) number K940686

Across registries

2 registries list this device

FDA 510(k) K202009 decided 22 Mar 2021 Active· +1 more in the status table
FDA GUDID UDI-DI 00634782548292 listed 27 Apr 2018 Listed

Timeline

3 dated events

8 Jul 1994 Cleared FDA 510(k) K940686
27 Apr 2018 Listed FDA GUDID 00634782548292
22 Mar 2021 Cleared FDA 510(k) K202009

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name: Adtemp™
Generic name: Electronic thermometer probe cover
Model / Ref / Catalog: 416-5000

Primary DI / UDI-DI: 00634782548292
510(k) Number: K202009
K940686
FDA product code: FLL
GMDN term: Electronic thermometer probe cover

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

Similar devices in this category

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Properties

Over-the-counter
Lot / batch number

Other properties (13, all answered No)