Apk S810-205D0

by Apk Technology

Apk S810-205D0 is a Class II device made by Apk Technology, cleared under FDA 510(k) K082846 on 3 Apr 2009 and listed in FDA GUDID since 15 Nov 2023 (UDI-DI 06946725537923), 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	Number06946725537923 UDI-DI	Date15 Nov 2023Listed	StatusListed GUDID: in commercial distribution
United States	FDA 510(k)SESE from GUDID Substantially Equivalent · Traditional	NumberK082846	Date3 Apr 2009Decided	StatusActive

Official records

AccessGUDID record UDI-DI 06946725537923
FDA 510(k) database 510(k) number K082846

Across registries

2 registries list this device

FDA 510(k) K082846 decided 3 Apr 2009 Active
FDA GUDID UDI-DI 06946725537923 listed 15 Nov 2023 Listed

Timeline

2 dated events

3 Apr 2009 Cleared FDA 510(k) K082846
15 Nov 2023 Listed FDA GUDID 06946725537923

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name: Apk
Generic name: Pulse Co-oximeter probe, single-use
Model / reference: S810-205D0

Primary DI / UDI-DI: 06946725537923
510(k) Number: K082846
FDA product code: DQA
GMDN term: Pulse Co-oximeter probe, single-use

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

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See all devices from Apk Technology →

Properties

Single use
Prescription use
Lot / batch number
Expiration date
Manufacturing date

Other properties (10, all answered No)