Reusable Sensor - Ear CST064-3130

Reusable Sensor - Ear CST064-3130 is a Class II device made by Mediaid Inc, cleared under FDA 510(k) K041964 on 14 Sep 2004 and listed in FDA GUDID since 6 Dec 2016 (UDI-DI B425CST06431302), 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	NumberB425CST06431302 UDI-DI	Date6 Dec 2016Listed	StatusListed GUDID: in commercial distribution
United States	FDA 510(k)SESE from GUDID Substantially Equivalent · Traditional	NumberK041964	Date14 Sep 2004Decided	StatusActive

Official records

FDA 510(k) database 510(k) number K041964

Across registries

2 registries list this device

FDA 510(k) K041964 decided 14 Sep 2004 Active
FDA GUDID UDI-DI B425CST06431302 listed 6 Dec 2016 Listed

Timeline

2 dated events

14 Sep 2004 Cleared FDA 510(k) K041964
6 Dec 2016 Listed FDA GUDID B425CST06431302

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name: Reusable Sensor - Ear
Generic name: Pulse oximeter, line-powered
Model / reference: CST064-3130

Primary DI / UDI-DI: B425CST06431302
510(k) Number: K041964
FDA product code: DQA
GMDN term: Pulse oximeter, line-powered

Device class: Class II
Regulation number: 870.2700
GUDID distribution status: In Commercial Distribution

Other devices from Mediaid Inc

See all devices from Mediaid Inc →

Properties

Prescription use
Serial number
Manufacturing date

Other properties (12, all answered No)