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Apk 10489

by APK Technology Co., Ltd.

Apk 10489 is a Class II device made by APK Technology Co., Ltd., cleared under FDA 510(k) K172981 on 8 Jun 2018 and listed in FDA GUDID since 21 Aug 2025 (UDI-DI 06946725500750), active as of 12 Nov 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 12 Nov 2026

Documents

510(k) K172981

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 12 Nov 2026.

Regulatory status

as of registry sync 12 Nov 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number06946725500750 UDI-DI Date21 Aug 2025ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK172981 Date8 Jun 2018DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K172981 decided 8 Jun 2018 Active
  • FDA GUDID UDI-DI 06946725500750 listed 21 Aug 2025 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K172981
  2. Listed FDA GUDID 06946725500750

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Apk
Generic name
Pulse Co-oximeter probe, reusable
Model / reference
10489
Primary DI / UDI-DI
06946725500750
510(k) Number
FDA product code
DQA
GMDN term
Pulse Co-oximeter probe, reusable
Device class
Class II
Regulation number
870.2700
GUDID distribution status
In Commercial Distribution

Related devices

Category: Pulse Co-oximeter probe, reusable

Cleared under the same submission (K172981)

and 8 more cleared under K172981

Other devices from APK Technology Co., Ltd.

See all devices from APK Technology Co., Ltd. →

Properties

  • Prescription use
  • Serial number
  • Expiration date
  • Manufacturing date
Other properties (11, all answered No)