Vision EX5 Dre 061424

Vision EX5 Dre 061424 is a Class II device made by Avante, cleared under FDA 510(k) K140812 on 7 Aug 2014 and listed in FDA GUDID since 1 Feb 2017 (UDI-DI 00815871022262), 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	Number00815871022262 UDI-DI	Date1 Feb 2017Listed	StatusListed GUDID: in commercial distribution
United States	FDA 510(k)SESE from GUDID Substantially Equivalent · Traditional	NumberK140812	Date7 Aug 2014Decided	StatusActive

Official records

AccessGUDID record UDI-DI 00815871022262
FDA 510(k) database 510(k) number K140812

Across registries

2 registries list this device

FDA 510(k) K140812 decided 7 Aug 2014 Active
FDA GUDID UDI-DI 00815871022262 listed 1 Feb 2017 Listed

Timeline

2 dated events

7 Aug 2014 Cleared FDA 510(k) K140812
1 Feb 2017 Listed FDA GUDID 00815871022262

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name: Vision EX5
Generic name: Medical monitor/light mount
Model / reference: DRE 061424

Primary DI / UDI-DI: 00815871022262
510(k) Number: K140812
FDA product code: FSY
GMDN term: Medical monitor/light mount

Device class: Class II
Regulation number: 878.4580
GUDID distribution status: In Commercial Distribution

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Properties

Serial number

Other properties (14, all answered No)