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Dolphin 2314

by OSI Optoelectronics

Dolphin 2314 is a Class II device made by OSI Optoelectronics, cleared under FDA 510(k) K030952 on 19 May 2003 and listed in FDA GUDID since 11 Jan 2017 (UDI-DI 00859998006293), 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) K030952

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 Number00859998006293 UDI-DI Date11 Jan 2017ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Special NumberK030952 Date19 May 2003DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K030952 decided 19 May 2003 Active
  • FDA GUDID UDI-DI 00859998006293 listed 11 Jan 2017 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K030952
  2. Listed FDA GUDID 00859998006293

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Dolphin
Generic name
Pulse oximeter probe, single-use
Model / reference
2314
Primary DI / UDI-DI
00859998006293
510(k) Number
FDA product code
DQA
GMDN term
Pulse oximeter probe, single-use
Device class
Class II
Regulation number
870.2700
GUDID distribution status
In Commercial Distribution

Related devices

Category: Pulse oximeter probe, single-use

Cleared under the same submission (K030952)

and 8 more cleared under K030952

Similar devices in this category

Other devices filed under Pulse oximeter probe, single-use.

Other devices from OSI Optoelectronics

  • BluSat 4343

    Class II

  • Dolphin 2311

    Class II

  • Dolphin 3312-V

    Class II

  • Dolphin 2312

    Class II

See all devices from OSI Optoelectronics →

Properties

  • Single use
  • Prescription use
  • Lot / batch number
  • Manufacturing date
Other properties (11, all answered No)