Care One 67-50K

by Ahold U.S.A., Inc.

Care One 67-50K is a Class II device made by Ahold U.S.A., Inc., cleared under FDA 510(k) K082641 on 10 Nov 2008 and listed in FDA GUDID since 23 Apr 2021 (UDI-DI 00041520105134), 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	Number00041520105134 UDI-DI	Date23 Apr 2021Listed	StatusListed GUDID: in commercial distribution
United States	FDA 510(k)SESE from GUDID Substantially Equivalent · Special	NumberK082641	Date10 Nov 2008Decided	StatusActive

Official records

AccessGUDID record UDI-DI 00041520105134
FDA 510(k) database 510(k) number K082641

Across registries

2 registries list this device

FDA 510(k) K082641 decided 10 Nov 2008 Active
FDA GUDID UDI-DI 00041520105134 listed 23 Apr 2021 Listed

Timeline

2 dated events

10 Nov 2008 Cleared FDA 510(k) K082641
23 Apr 2021 Listed FDA GUDID 00041520105134

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name: Care One
Generic name: Pulse oximeter probe, reusable
Model / reference: 67-50K

Primary DI / UDI-DI: 00041520105134
510(k) Number: K082641
FDA product code: DQA
GMDN term: Pulse oximeter probe, reusable

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

Other devices from Ahold U.S.A., Inc.

See all devices from Ahold U.S.A., Inc. →

Properties

Over-the-counter
Lot / batch number

Other properties (13, all answered No)