Skip to content

1BYONE Jpd-500D

by 1BYONEPRODUCTS Inc.

1BYONE Jpd-500D is a Class II device made by 1BYONEPRODUCTS Inc., cleared under FDA 510(k) K140582 on 28 Aug 2014 and listed in FDA GUDID since 10 Nov 2016 (UDI-DI 00863696000323), 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) K140582

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 Number00863696000323 UDI-DI Date10 Nov 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK140582 Date28 Aug 2014DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K140582 decided 28 Aug 2014 Active
  • FDA GUDID UDI-DI 00863696000323 listed 10 Nov 2016 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K140582
  2. Listed FDA GUDID 00863696000323

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
1BYONE
Generic name
Pulse oximeter
Model / reference
JPD-500D
Primary DI / UDI-DI
00863696000323
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

Related devices

Category: Pulse oximeter

Cleared under the same submission (K140582)

and 8 more cleared under K140582

Similar devices in this category

Other devices filed under Pulse oximeter.

Other devices from 1BYONEPRODUCTS Inc.

See all devices from 1BYONEPRODUCTS Inc. →

Properties

Other properties (15, all answered No)