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Santamedical Sm-ACLED150

by Xiamen Acurio Instrument Co., Ltd

Santamedical Sm-ACLED150 is a Class II device made by Xiamen Acurio Instrument Co., Ltd, cleared under FDA 510(k) K180685 on 29 Nov 2018 and listed in FDA GUDID since 1 Jun 2020 (UDI-DI 00810053630013), 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

510(k) K180685

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00810053630013 UDI-DI Date1 Jun 2020ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK180685 Date29 Nov 2018DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K180685 decided 29 Nov 2018 Active
  • FDA GUDID UDI-DI 00810053630013 listed 1 Jun 2020 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K180685
  2. Listed FDA GUDID 00810053630013

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Santamedical
Generic name
Pulse oximeter
Model / reference
SM-ACLED150
Primary DI / UDI-DI
00810053630013
510(k) Number
FDA product code
DQA
GMDN term
Pulse oximeter
Device class
Class II
Regulation number
870.2700
GUDID distribution status
In Commercial Distribution
MRI safety
MR Unsafe

Related devices

Category: Pulse oximeter

Cleared under the same submission (K180685)

and 1 more cleared under K180685

Similar devices in this category

Other devices filed under Pulse oximeter.

Other devices from Xiamen Acurio Instrument Co., Ltd

  • Santamedical As-301-L

    Class II

  • Dr. Sana As-302-L

    Class II

  • acurio AS-302

    Class II

  • acurio AS-301

    Class II

See all devices from Xiamen Acurio Instrument Co., Ltd →

Properties

  • Lot / batch number
  • Serial number
  • Expiration date
  • Manufacturing date
Other properties (11, all answered No)