Adtemp™ 413RK

by American Diagnostic Corporation

Adtemp™ 413RK is a Class II device made by American Diagnostic Corporation, cleared under FDA 510(k) K940686 on 8 Jul 1994 and listed in FDA GUDID since 21 Sep 2016 (UDI-DI 00634782053642), 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

FDA submission, from GUDID

Trust

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

Region	Authorization	Number	Date	Status
United States	GUDID listing	Number00634782053642 UDI-DI	Date21 Sep 2016Listed	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 00634782053642
FDA 510(k) database 510(k) number K940686

Across registries

2 registries list this device

FDA 510(k) K940686 decided 8 Jul 1994 Active
FDA GUDID UDI-DI 00634782053642 listed 21 Sep 2016 Listed

Timeline

2 dated events

8 Jul 1994 Cleared FDA 510(k) K940686
21 Sep 2016 Listed FDA GUDID 00634782053642

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name: Adtemp™
Generic name: Intermittent electronic patient thermometer
Model / Ref / Catalog: 413RK

Primary DI / UDI-DI: 00634782053642
510(k) Number: K940686
FDA product code: FLL
GMDN term: Intermittent electronic patient thermometer

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

Similar devices in this category

Other devices filed under Intermittent electronic patient thermometer.

Other devices from American Diagnostic Corporation

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Properties

Over-the-counter
Convenience kit
Lot / batch number

Other properties (12, all answered No)