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ViaMed 13311

by Rece International Corp.

ViaMed 13311 is a Class II device made by Rece International Corp., cleared under FDA 510(k) K043286 on 13 Jan 2005 and listed in FDA GUDID since 23 May 2017 (UDI-DI 00811382010675), 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) K043286

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 Number00811382010675 UDI-DI Date23 May 2017ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK043286 Date13 Jan 2005DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K043286 decided 13 Jan 2005 Active
  • FDA GUDID UDI-DI 00811382010675 listed 23 May 2017 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K043286
  2. Listed FDA GUDID 00811382010675

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
ViaMed
Generic name
Aneroid manual sphygmomanometer
Model / reference
13311
Primary DI / UDI-DI
00811382010675
510(k) Number
FDA product code
DXQ
GMDN term
Aneroid manual sphygmomanometer
Device class
Class II
Regulation number
870.1120
GUDID distribution status
In Commercial Distribution

Related devices

Category: Aneroid manual sphygmomanometer

Cleared under the same submission (K043286)

and 4 more cleared under K043286

Similar devices

Other devices filed under FDA product code DXQ (Blood Pressure Cuff).

Other devices from Rece International Corp.

See all devices from Rece International Corp. →

Properties

  • Lot / batch number
  • Manufacturing date
Other properties (13, all answered No)