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All Purpose Cuff 98-0082-10

by SunTech Medical, Inc

All Purpose Cuff 98-0082-10 is a Class II device made by SunTech Medical, Inc, cleared under FDA 510(k) K051904 on 9 Sep 2005 and listed in FDA GUDID since 28 Jul 2017 (UDI-DI 10840935107187), 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) K051904

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 Number10840935107187 UDI-DI Date28 Jul 2017ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Abbreviated NumberK051904 Date9 Sep 2005DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K051904 decided 9 Sep 2005 Active
  • FDA GUDID UDI-DI 10840935107187 listed 28 Jul 2017 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K051904
  2. Listed FDA GUDID 10840935107187

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
All Purpose Cuff
Generic name
Blood pressure cuff, reusable
Model / reference
98-0082-10
Primary DI / UDI-DI
10840935107187
510(k) Number
FDA product code
DXQ
GMDN term
Blood pressure cuff, reusable
Device class
Class II
Regulation number
870.1120
GUDID distribution status
In Commercial Distribution

Similar devices

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

Other devices from SunTech Medical, Inc

See all devices from SunTech Medical, Inc →

Properties

  • Prescription use
  • Lot / batch number
Other properties (13, all answered No)