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Apk S533-090

by APK Technology Co., Ltd.

Apk S533-090 is a Class II device made by APK Technology Co., Ltd., cleared under FDA 510(k) K082846 on 3 Apr 2009 and listed in FDA GUDID since 9 Apr 2025 (UDI-DI 06946725546239), 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) K082846

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 Number06946725546239 UDI-DI Date9 Apr 2025ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK082846 Date3 Apr 2009DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K082846 decided 3 Apr 2009 Active
  • FDA GUDID UDI-DI 06946725546239 listed 9 Apr 2025 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K082846
  2. Listed FDA GUDID 06946725546239

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  • Withdrawn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
S533-090
Primary DI / UDI-DI
06946725546239
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 (K082846)

and 8 more cleared under K082846

Other devices from APK Technology Co., Ltd.

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

Properties

  • Single use
  • Prescription use
  • Lot / batch number
  • Expiration date
  • Manufacturing date
Other properties (10, all answered No)