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Leader 5279823

by Cardinal Health 110, Inc.

Leader 5279823 is a Class II device made by Cardinal Health 110, Inc., cleared under FDA 510(k) K082542 on 17 Sep 2008 and listed in FDA GUDID since 23 Mar 2017 (UDI-DI 00096295129328), active as of 23 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 23 Oct 2026

Documents

510(k) K082542

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00096295129328 UDI-DI Date23 Mar 2017ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK082542 Date17 Sep 2008DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K082542 decided 17 Sep 2008 Active
  • FDA GUDID UDI-DI 00096295129328 listed 23 Mar 2017 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K082542
  2. Listed FDA GUDID 00096295129328

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Leader
Generic name
Aneroid manual sphygmomanometer
Model / Ref / Catalog
5279823
Primary DI / UDI-DI
00096295129328
510(k) Number
FDA product code
DXN
GMDN term
Aneroid manual sphygmomanometer
Device class
Class II
Regulation number
870.1130
GUDID distribution status
In Commercial Distribution

Related devices

Category: Aneroid manual sphygmomanometer

Cleared under the same submission (K082542)

and 8 more cleared under K082542

Similar devices

Other devices filed under FDA product code DXN (System, Measurement, Blood-Pressure, Non-Invasive).

Other devices from Cardinal Health 110, Inc.

See all devices from Cardinal Health 110, Inc. →

Properties

  • Over-the-counter
  • Convenience kit
  • Lot / batch number
Other properties (12, all answered No)